K915779 is an FDA 510(k) clearance for the AFFINITY BED MODEL 3600 SERIES. This device is classified as a Table, Obstetric (and Accessories) (Class II - Special Controls, product code KNC).
Submitted by Hill-Rom, Inc. (Batesville, US). The FDA issued a Cleared decision on February 24, 1993, 428 days after receiving the submission on December 24, 1991.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4900.
| 510(k) Number | K915779 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 24, 1991 |
| Decision Date | February 24, 1993 |
| Days to Decision | 428 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | KNC — Table, Obstetric (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4900 |