510(k) K061857
K061857 is an FDA 510(k) premarket notification submitted by Bio Compression Systems, Inc. for the device "MODEL MULTI-FLO IC-1545-KT/-F INTERMITTENT CIRCULATOR". The FDA issued a decision of Substantially Equivalent on August 1, 2006. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Bio Compression Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 1, 2006
- Date Received
- June 30, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Sleeve, Limb, Compressible
- Device Class
- Class II
- Regulation Number
- 870.5800
- Review Panel
- CV
- Submission Type