Clearance Summary
THE GENESIS BED FROM HILL-ROM, MODEL 355 SERIES received FDA 510(k) clearance under submission number K914309, 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 1992-04-20.
- Submission: K914309
- Applicant / Sponsor: Hill-Rom, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4900
- Decision date: 1992-04-20
Classification & Regulation
This clearance is catalogued under FDA product code HDD and 21 CFR 884.4900, within the Obstetrics/Gynecology review panel as a Class II device.