Panels › General Hospital › Product code FRF · Class 2
Cleaner, Air, Medical Recirculating
Regulation 880.5045
1510(k)s in 12 months (53 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in FRF
| Company | 510(k)s | Recalls |
|---|---|---|
| Airsonett AB | 2 | 0 |
| Bionaire Corp. | 2 | 0 |
| Cerrozone | 2 | 0 |
| Hmi Industries, Inc. | 2 | 0 |
| Medicor USA , Ltd. | 2 | 0 |
| Norelco Consumer Products Co. | 2 | 0 |
| The Rival Co. | 2 | 0 |
| Abatement Technologies, Inc. | 1 | 0 |
| Air Innovations, Inc. | 1 | 0 |
| Airex, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 29, 1976 | K760921 | AIR PURIFIER Vitaire Corp. | FRF |
| Dec 16, 1976 | K760879 | ROOM AIR PURIFIER (TEX-DYN) Texas Dynamics | FRF |
| Sep 15, 1976 | K760481 | FILTER, PARTICULATE ARRESTING Miles Laboratories, Inc. | FRF |
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