The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Ibed Wireless With Ibed Awareness.
| Device ID | K103536 |
| 510k Number | K103536 |
| Device Name: | IBED WIRELESS WITH IBED AWARENESS |
| Classification | Bed, Ac-powered Adjustable Hospital |
| Applicant | STRYKER CORPORATION 3800 E. CENTRE AVE Portage, MI 49002 |
| Contact | Diane Horwitz |
| Correspondent | William Sammons INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | FNL |
| CFR Regulation Number | 880.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-12-01 |
| Decision Date | 2010-12-16 |
| Summary: | summary |