Panels › Anesthesiology › Product code BTM · Class 2
Ventilator, Emergency, Manual (Resuscitator)
Regulation 868.5915
2510(k)s in 12 months (210 all time)
1recalls in 12 months (97 all time)
80recalls that name a 510(k)
Top companies in BTM
| Company | 510(k)s | Recalls |
|---|---|---|
| Unomedical | 0 | 23 |
| Ventlab Corp. | 2 | 19 |
| Ambu, Inc. | 15 | 1 |
| Sun Med, LLC | 0 | 14 |
| Puritan Bennett Corp. | 13 | 0 |
| Medical Marketing Concepts | 11 | 0 |
| Vyaire Medical | 0 | 11 |
| SunMed Holdings, LLC | 0 | 10 |
| Laerdal Medical AS | 3 | 4 |
| Life Design Systems, Inc. | 7 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 17, 1980 | K802813 | PMR-2 PURITAN MANUAL RESUSCITATOR Puritan Bennett Corp. | BTM |
| Oct 10, 1980 | K802231 | AIR VIVA II General Medical Co. | BTM |
| Sep 26, 1980 | K802081 | AULD BAGGER KIT Modern Medical Systems Co. | BTM |
| Nov 13, 1979 | K792118 | AIR-SHIELDS RESUSCITATORS Narco Air-Shields | BTM |
| Aug 22, 1979 | K791468 | RESUSCI-BAG-VALVE Concept, Inc. | BTM |
| Mar 14, 1978 | K780216 | LIFESAVER, MANUAL #5160 Hudson Oxygen Therapy Sales Co. | BTM |
| Aug 19, 1977 | K771350 | AMBU RESUSCITATOR Air-Shields, Inc. | BTM |
| Aug 2, 1977 | K771175 | RESUSCITATOR, MS30 Mckesson Corp. | BTM |
| Jan 26, 1977 | K761065 | NEONATAL RESUSCITATOR, SAMSON Dem Medical, Inc. | BTM |
| Nov 24, 1976 | K761025 | BAG RESUSCITATOR Robert Shaw Controls Co. | BTM |
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