K911246 is an FDA 510(k) clearance for the THE MEDISCUS PEDCARE MANAGEMENT SYSTEM-MODEL 2. This device is classified as a Bed, Air Fluidized (Class II - Special Controls, product code INX).
Submitted by The Medical Group, Inc. (Buena Park, US). The FDA issued a Cleared decision on June 6, 1991, 77 days after receiving the submission on March 21, 1991.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5160.
| 510(k) Number | K911246 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 1991 |
| Decision Date | June 06, 1991 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | INX — Bed, Air Fluidized |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5160 |