510(k) K971892
K971892 is an FDA 510(k) premarket notification submitted by Biomedical Horizons, Inc. for the device "BIOMEDICAL HORIZONS INC. COMPRESSION PUMP, MODEL 651". The FDA issued a decision of Substantially Equivalent on August 5, 1998. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Biomedical Horizons, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 5, 1998
- Date Received
- May 22, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sleeve, Limb, Compressible
- Device Class
- Class II
- Regulation Number
- 870.5800
- Review Panel
- CV
- Submission Type