Clearance Summary
AFFINITY BED MODEL 3600 SERIES received FDA 510(k) clearance under submission number K915779, sponsored by Hill-Rom, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1993-02-24.
- Submission: K915779
- Applicant / Sponsor: Hill-Rom, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4900
- Decision date: 1993-02-24
Classification & Regulation
This clearance is catalogued under FDA product code KNC and 21 CFR 884.4900, within the Obstetrics/Gynecology review panel as a Class II device.