K882092 is an FDA 510(k) clearance for the CLINI-CARE + PRESSURE ULCER TREATMENT SYSTEM. This device is classified as a Mattress, Air Flotation, Alternating Pressure (Class II - Special Controls, product code FNM).
Submitted by Gaymar Industries, Inc. (Orchard Park, US). The FDA issued a Cleared decision on July 13, 1988, 55 days after receiving the submission on May 19, 1988.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5550.
| 510(k) Number | K882092 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 19, 1988 |
| Decision Date | July 13, 1988 |
| Days to Decision | 55 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 |