K780502 is an FDA 510(k) clearance for the NOVA AIR FLOATATION SYSTEM. This device is classified as a Mattress, Air Flotation, Alternating Pressure (Class II - Special Controls, product code FNM).
Submitted by Nova Health Systems, Inc.. The FDA issued a Cleared decision on April 10, 1978, 12 days after receiving the submission on March 29, 1978.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5550.
| 510(k) Number | K780502 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 29, 1978 |
| Decision Date | April 10, 1978 |
| Days to Decision | 12 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FNM — Mattress, Air Flotation, Alternating Pressure |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5550 |