Panels › Anesthesiology › Product code CBK · Class 2
Ventilator, Continuous, Facility Use
Regulation 868.5895
4510(k)s in 12 months (505 all time)
23recalls in 12 months (336 all time)
306recalls that name a 510(k)
Top companies in CBK
| Company | 510(k)s | Recalls |
|---|---|---|
| Hamilton Medical AG | 35 | 31 |
| Philips Respironics | 0 | 54 |
| Draeger Medical AG & Co. KG | 14 | 26 |
| Puritan Bennett Corp. | 34 | 1 |
| Newport Medical Instruments, Inc. | 17 | 12 |
| Respironics, Inc. | 14 | 14 |
| Covidien | 4 | 23 |
| Bird Products Corp. | 21 | 0 |
| Respironics California, Inc. | 8 | 13 |
| Bio-Med Devices, Inc. | 9 | 8 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 10, 1978 | K780188 | INFANT VENTILATOR MODEL 100 Sechrist Industries, Inc. | CBK |
| Nov 28, 1977 | K772065 | CRITICAL CARE VENTILATOR 2 Ohio Medical Products | CBK |
| Aug 5, 1977 | K771039 | RESPIRATOR, PROTABLE, VOLUME CONTROLLED Dept. of the Navy | CBK |
| Feb 1, 1977 | K770132 | MODEL LP-3 PORTABLE VOLUME VENTILATOR Life Products, Inc. | CBK |
| Sep 27, 1976 | K760663 | MVP-10 PEDIATRIC/NEONATAL VENTILATOR Air-Shields, Inc. | CBK |
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