Clearance Summary
VACUUM POWER BODY FLUID SUCTION APPARATUS received FDA 510(k) clearance under submission number K926140, 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 1993-07-27.
- Submission: K926140
- Applicant / Sponsor: Hill-Rom, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6740
- Decision date: 1993-07-27
Classification & Regulation
This clearance is catalogued under FDA product code KDP and 21 CFR 880.6740, within the General Hospital review panel as a Class II device.