K945629 is an FDA 510(k) clearance for the MICOS MICROPULSE(TM) ALTERNATING PRESSURE MATTRESS. This device is classified as a Mattress, Air Flotation, Alternating Pressure (Class II - Special Controls, product code FNM).
Submitted by Micos Medical Systems (Hickory Corners, US). The FDA issued a Cleared decision on April 14, 1995, 149 days after receiving the submission on November 16, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5550.
| 510(k) Number | K945629 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 16, 1994 |
| Decision Date | April 14, 1995 |
| Days to Decision | 149 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FNM — Mattress, Air Flotation, Alternating Pressure |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5550 |