510(k) K061857

MODEL MULTI-FLO IC-1545-KT/-F INTERMITTENT CIRCULATOR by Bio Compression Systems, Inc. — Product Code JOW

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