510(k) K082660 ยท MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
V60 VENTILATOR, MODEL V8000
| Applicant | Respironics California, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Jan 9, 2009 |
| Received | Sep 12, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082660
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 22, 2021 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Open, Classified |
MNT | None listed |
| Jan 22, 2021 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Open, Classified |
MNT | None listed |
| Jan 22, 2021 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1053615 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Open, Classified |
MNT | None listed |
| Jan 22, 2021 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1053616 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Open, Classified |
MNT | None listed |
| Jan 22, 2021 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Open, Classified |
MNT | None listed |
| Jan 22, 2021 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Open, Classified |
MNT | None listed |
| Jan 22, 2021 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1076709 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Open, Classified |
MNT | None listed |
| Jan 22, 2021 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers Open, Classified |
MNT | None listed |
| Jan 22, 2021 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number R1076709 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers Open, Classified |
MNT | None listed |
| Jan 22, 2021 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Open, Classified |
MNT | None listed |
| Jan 22, 2021 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1076717 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Open, Classified |
MNT | None listed |
| Jan 22, 2021 | Respironics California, LLC Philips Respironics V60 Plus Ventilator Part Number 1137276 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidif Open, Classified |
MNT | None listed |
| Jan 22, 2021 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Open, Classified |
MNT | None listed |
| Jan 22, 2021 | Respironics California, LLC Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidif Open, Classified |
MNT | None listed |
| Jan 22, 2021 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifier Open, Classified |
MNT | None listed |
| Jan 22, 2021 | Respironics California, LLC Philips Respironics V680 Ventilator Part Number 850011 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Open, Classified |
MNT | None listed |
| Jan 6, 2021 | Respironics California, LLC PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1 - Product Usage: The ventilator is intended to be used only with various combinations of Respironics-recommended patien Open, Classified |
MNT | None listed |
| Oct 30, 2020 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Terminated |
MNT | None listed |
| Oct 30, 2020 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Terminated |
MNT | None listed |
| Oct 30, 2020 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1053615 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Terminated |
MNT | None listed |
| Oct 30, 2020 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1053616 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Terminated |
MNT | None listed |
| Oct 30, 2020 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Terminated |
MNT | None listed |
| Oct 30, 2020 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Terminated |
MNT | None listed |
| Oct 30, 2020 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1076709 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Terminated |
MNT | None listed |
| Oct 30, 2020 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers Terminated |
MNT | None listed |
| Oct 30, 2020 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number R1076709 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers Terminated |
MNT | None listed |
| Oct 30, 2020 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Terminated |
MNT | None listed |
| Oct 30, 2020 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1076717 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Terminated |
MNT | None listed |
| Oct 30, 2020 | Respironics California, LLC Philips Respironics V60 Plus Ventilator Part Number 1137276 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidif Terminated |
MNT | None listed |
| Oct 30, 2020 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Terminated |
MNT | None listed |
| Oct 30, 2020 | Respironics California, LLC Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidif Terminated |
MNT | None listed |
| Oct 30, 2020 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifier Terminated |
MNT | None listed |
| Oct 30, 2020 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number U1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers Terminated |
MNT | None listed |
| Oct 30, 2020 | Respironics California, LLC Philips Respironics V680 Ventilator Part Number 850011 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Terminated |
MNT | None listed |
| Mar 5, 2020 | Respironics California, LLC Philips V60 Ventilators with Power Management PCBA part number 1055906 Open, Classified |
MNT | None listed |
| Sep 11, 2019 | Respironics California, LLC Respironics V60 Ventilator, Service # 850008, REF: 1053613, 1053614, 1053617, 1053614 Open, Classified |
MNT | None listed |
| Sep 11, 2019 | Respironics California, LLC Respironics RP-UI Assy, V60 Ventilators User Interface RP-Kits, REF/P/N:
453561528931,
453561528941,
453561536451,
453561536461 Open, Classified |
MNT | None listed |
| Sep 11, 2019 | Respironics California, LLC Respironics RP-Touch Screen, V60/V680 Ventilator Serviced with Touchscreen RP Kit 453561511951 containing a touchscreen labeled as raw part number 1132318 Revision C Open, Classified |
MNT | None listed |
| Sep 11, 2019 | Respironics California, LLC Respironics V680 Ventilator, Service # 850011, (OUS Only) Open, Classified |
MNT | None listed |
| May 18, 2017 | Respironics California Inc Philips V60 Ventilators, Material No. 850008, 1053613, 1053614, 1053615, 1053616, 1053617, 1076715, 1076716, 1076717, DU1053617, U1053617.
Old Material No. 850008, 989805628251, 989805612101, 9898056 Terminated |
MNT | None listed |
| Jun 17, 2013 | Respironics California Inc Respironics V60 Ventilator, Model #V60
Respironics Material P/N (Philips 12 Digit P/N):
85008 (85008)
1053613 (989805628251)
1053614 (989805612101)
1053615 (989805613391)
1053616 (989805613661)
105 Terminated |
MNT | None listed |
| Aug 31, 2012 | Respironics California Inc V60 Ventilator, Continuous Ventilator, Model# V60, PN 1056490
Product Usage:
The V60 Ventilator is an assist Ventilator and is intended to augment patient breathing. It is intended for spontaneously Terminated |
MNT | None listed |
| Nov 24, 2010 | Respironics California Inc Respironics V60 Ventilator, manufactured by Respironics California Inc. in Carlsbad, CA. Terminated |
MNT | None listed |
| Nov 11, 2009 | Respironics California Inc RESPIRONICS V60 VENTILATOR Terminated |
MNT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.