Clearance Summary
IBED WIRELESS WITH IBED AWARENESS received FDA 510(k) clearance under submission number K103536, sponsored by Stryker Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2010-12-16.
- Submission: K103536
- Applicant / Sponsor: Stryker Corporation
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5100
- Decision date: 2010-12-16
Classification & Regulation
This clearance is catalogued under FDA product code FNL and 21 CFR 880.5100, within the General Hospital review panel as a Class II device.