Clearance Summary
BIOMEDICAL HORIZONS INC. COMPRESSION PUMP, MODEL 651 received FDA 510(k) clearance under submission number K971892, sponsored by Biomedical Horizons, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1998-08-05.
- Submission: K971892
- Applicant / Sponsor: Biomedical Horizons, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5800
- Decision date: 1998-08-05
Classification & Regulation
This clearance is catalogued under FDA product code JOW and 21 CFR 870.5800, within the Cardiovascular review panel as a Class II device.