510(k) K102985 ยท MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, Apr 5, 2011 |
| Received | Oct 7, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102985
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 28, 2023 | Philips Respironics, Inc. Philips Respironics V60/V60 Plus Ventilator,
PCBA Part Number: 453561544461
V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines) Open, Classified |
MNT | None listed |
| Apr 18, 2022 | Respironics California, LLC Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709, 1076716, 1076717, 1137292, DU1053617, U1053617, R1053618, R1076709) Open, Classified |
MNT | None listed |
| Apr 18, 2022 | Respironics California, LLC Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276) Open, Classified |
MNT | None listed |
| Feb 25, 2022 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1053617 Open, Classified |
MNT | None listed |
| Feb 25, 2022 | Respironics California, LLC Philips Respironics V60 Plus Ventilator Part Number 1138747 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 |
| Feb 1, 2017 | Respironics California Inc Philips V60 Ventilator with Version 2.20 Software,
Description: V
60 Ventilator,Intl Opt: CFLEX,AVAPS,PPV
V60 Ventilator,Intl Opt: CFLEX,AVAPS
V60 Ventilator,Intl Opt: None
V60 Ventilator,English Op 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.