K202964 is an FDA 510(k) clearance for the iBed Wireless with iBed Mobile. 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 June 18, 2021, 261 days after receiving the submission on September 30, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5100.
| 510(k) Number | K202964 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2020 |
| Decision Date | June 18, 2021 |
| Days to Decision | 261 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 |