K946208 is an FDA 510(k) clearance for the VOLKER NURSING BED MODEL 2080E & 2090E. This device is classified as a Bed, Ac-powered Adjustable Hospital (Class II - Special Controls, product code FNL).
Submitted by Volker Healthcare, Inc. (Great Neck,, US). The FDA issued a Cleared decision on March 14, 1995, 83 days after receiving the submission on December 21, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5100.
| 510(k) Number | K946208 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 1994 |
| Decision Date | March 14, 1995 |
| Days to Decision | 83 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 |