K946149 is an FDA 510(k) clearance for the STRYKER AGILITY INTENSIVE CARE BED. This device is classified as a Bed, Ac-powered Adjustable Hospital (Class II - Special Controls, product code FNL).
Submitted by Stryker Medical (Kalamazoo, US). The FDA issued a Cleared decision on March 14, 1995, 88 days after receiving the submission on December 16, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5100.
| 510(k) Number | K946149 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 1994 |
| Decision Date | March 14, 1995 |
| Days to Decision | 88 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 |