Clearance Summary
WHEELED STRETCHER received FDA 510(k) clearance under submission number K961437, sponsored by Hill-Rom, Inc.. 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 1996-06-03.
- Submission: K961437
- Applicant / Sponsor: Hill-Rom, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6910
- Decision date: 1996-06-03
Classification & Regulation
This clearance is catalogued under FDA product code FPO and 21 CFR 880.6910, within the General Hospital review panel as a Class II device.