K924973 is an FDA 510(k) clearance for the DYLNAMEDICS A.S.A.P.. This device is classified as a Bed, Air Fluidized (Class II - Special Controls, product code INX).
Submitted by Dynamedics, Inc. (Canada, N6b3n5, CA). The FDA issued a Cleared decision on October 15, 1993, 380 days after receiving the submission on September 30, 1992.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5160.
| 510(k) Number | K924973 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 1992 |
| Decision Date | October 15, 1993 |
| Days to Decision | 380 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | INX — Bed, Air Fluidized |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5160 |