Panels › Anesthesiology › Product code NOU · Class 2
Continuous, Ventilator, Home Use
Regulation 868.5895
0510(k)s in 12 months (7 all time)
1recalls in 12 months (16 all time)
12recalls that name a 510(k)
Top companies in NOU
| Company | 510(k)s | Recalls |
|---|---|---|
| Breas Medical AB | 3 | 5 |
| Philips Respironics, Inc. | 0 | 5 |
| Pulmonetic Systems, Inc. | 0 | 4 |
| Respironics California, Inc. | 2 | 0 |
| Ge Healthcare, Breas Medical AB | 1 | 0 |
| Human Design Medical Llc | 0 | 1 |
| Ventec Life Systems, Inc. | 0 | 1 |
| Versamed , Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 13, 2025 | K233452 | Vivo 45 LS Breas Medical AB, SE | NOU |
| Jan 27, 2021 | K193586 | Vivo 45 LS Breas Medical AB, SE | NOU |
| Nov 9, 2016 | K160481 | Vivo 60 Breas Medical AB, SE | NOU |
| Jun 18, 2013 | K123144 | VIVO 50 Ge Healthcare, Breas Medical AB, SE | NOU |
| Mar 16, 2004 | K034032 | PLV CONTINUUM VENTILATOR, MODEL P2000 Respironics California, Inc. | NOU |
| Nov 20, 2003 | K022750 | PLV CONTINUUM VENTILATOR, MODEL P1000 Respironics California, Inc. | NOU |
| Aug 13, 2003 | K021981 | IVENT 201 PORTABLE VENTILATOR Versamed , Ltd., IL | NOU |
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