Clearance Summary
VERSALET 7700 CARE CENTER, MODEL # 7700 received FDA 510(k) clearance under submission number K993051, sponsored by Hill-Rom Air-Shields. 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 2000-02-03.
- Submission: K993051
- Applicant / Sponsor: Hill-Rom Air-Shields
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5400
- Decision date: 2000-02-03
Classification & Regulation
This clearance is catalogued under FDA product code FMZ and 21 CFR 880.5400, within the General Hospital review panel as a Class II device.