Panels › General Hospital › Product code FNM · Class 2
Mattress, Air Flotation, Alternating Pressure
Regulation 880.5550
0510(k)s in 12 months (102 all time)
2recalls in 12 months (13 all time)
0recalls that name a 510(k)
Top companies in FNM
| Company | 510(k)s | Recalls |
|---|---|---|
| Kinetic Concepts, Inc. | 8 | 0 |
| Span-America Medical Systems, Inc. | 8 | 0 |
| Huntleigh Technology, Inc. | 5 | 0 |
| Hill-Rom Manufacturing, Inc. | 0 | 4 |
| 9th Wave, Inc. | 3 | 0 |
| Gaymar Industries, Inc. | 3 | 0 |
| Lumex, Inc. | 3 | 0 |
| Pegasus Airwave, Inc. | 3 | 0 |
| Plexus Medical | 3 | 0 |
| Bio Clinic Co. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 26, 1977 | K771463 | AERO PULSE ALTERNATING PRES. PUMP Medline Industries, Inc. | FNM |
| Dec 9, 1976 | K761012 | ALPHABED ALTERNATING PRESSURE PAD Nlowtron-Aire , Ltd. | FNM |
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