K103536 is an FDA 510(k) clearance for the IBED WIRELESS WITH IBED AWARENESS. This device is classified as a Bed, Ac-powered Adjustable Hospital (Class II - Special Controls, product code FNL).
Submitted by Stryker Corporation (Portage, US). The FDA issued a Cleared decision on December 16, 2010, 15 days after receiving the submission on December 1, 2010.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5100.
| 510(k) Number | K103536 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 2010 |
| Decision Date | December 16, 2010 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FNL — Bed, Ac-powered Adjustable Hospital |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5100 |