Panels › Anesthesiology › Product code MNT · Class 2
Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Regulation 868.5895
1510(k)s in 12 months (25 all time)
0recalls in 12 months (64 all time)
54recalls that name a 510(k)
Top companies in MNT
| Company | 510(k)s | Recalls |
|---|---|---|
| Respironics California, Inc. | 1 | 52 |
| Philips Respironics, Inc. | 0 | 7 |
| Respironics, Inc. | 6 | 1 |
| Breas Medical AB | 4 | 0 |
| Fisher & Paykel Healthcare Limited | 3 | 0 |
| Resmed Germany, Inc. | 3 | 0 |
| Puritan Bennett Corp. | 1 | 1 |
| Resmed, Ltd. | 1 | 1 |
| Bio-Med Devices, Inc. | 0 | 1 |
| DRE Medical Group Inc | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 12, 2019 | ResMed Ltd. ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150 Completed |
MNT | K122715 |
| Sep 11, 2019 | Respironics California, LLC Respironics V680 Ventilator, Service # 850011, (OUS Only) Open, Classified |
MNT | K082660 |
| 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 | K082660 |
| 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 | K082660 |
| Sep 11, 2019 | Respironics California, LLC Respironics V60 Ventilator, Service # 850008, REF: 1053613, 1053614, 1053617, 1053614 Open, Classified |
MNT | K082660 |
| 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 | K082660 K102985 |
| 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 | K102985 |
| 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 | K082660 K102985 |
| 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 | K082660 K102985 |
| Nov 24, 2010 | Respironics California Inc Respironics V60 Ventilator, manufactured by Respironics California Inc. in Carlsbad, CA. Terminated |
MNT | K082660 |
| Nov 11, 2009 | Respironics California Inc RESPIRONICS V60 VENTILATOR Terminated |
MNT | K082660 |
| Apr 24, 2008 | Respironics, Inc. Inv Circuit Assembly Box 10 CE model number 652002. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
MNT | K842876 |
| Jan 9, 2007 | Puritan Bennett Corporation Puritan Bennett KnightStar 330 Bi-Level Ventilator, Catalogue Numbers: Y-KS330-NA, Y-KS330-SD, DSY-KS330-NA, DSY-K5330-SD, DLY-KS330-NA & DLY-KS330-SD Terminated |
MNT | K003075 |
| Jan 6, 2004 | Bio-Med Devices, Inc. MVP-10 Pediatric/ Neonatal Volume Ventilator Terminated |
MNT | None listed |
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