K974254 is an FDA 510(k) clearance for the BENEFIT B3--- SERIES. This device is classified as a Bed, Ac-powered Adjustable Hospital (Class II - Special Controls, product code FNL).
Submitted by M.C. Healthcare Products, Inc. (Beamsville, Ontario, CA). The FDA issued a Cleared decision on December 16, 1997, 33 days after receiving the submission on November 13, 1997.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5100.
| 510(k) Number | K974254 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 1997 |
| Decision Date | December 16, 1997 |
| Days to Decision | 33 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 |