K901295 is an FDA 510(k) clearance for the PULMONAIR 40 PATIENT MANAGEMENT SYSTEM. This device is classified as a Bed, Flotation Therapy, Powered (Class II - Special Controls, product code IOQ).
Submitted by The Medical Group, Inc. (Buena Park, US). The FDA issued a Cleared decision on March 30, 1990, 10 days after receiving the submission on March 20, 1990.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5170.
| 510(k) Number | K901295 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 1990 |
| Decision Date | March 30, 1990 |
| Days to Decision | 10 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IOQ — Bed, Flotation Therapy, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5170 |