K915437 is an FDA 510(k) clearance for the CRITICAL CARE HOSPITAL BED (ICU/CCU). This device is classified as a Bed, Ac-powered Adjustable Hospital (Class II - Special Controls, product code FNL).
Submitted by Hill-Rom, Inc. (Batesville, US). The FDA issued a Cleared decision on June 11, 1992, 198 days after receiving the submission on November 26, 1991.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5100.
| 510(k) Number | K915437 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 26, 1991 |
| Decision Date | June 11, 1992 |
| Days to Decision | 198 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FNL — Bed, Ac-powered Adjustable Hospital |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5100 |