510(k) K171793

Sequential Circulator SC-2004FC-OC by Bio Compression Systems, Inc. — Product Code JOW

K171793 is an FDA 510(k) premarket notification submitted by Bio Compression Systems, Inc. for the device "Sequential Circulator SC-2004FC-OC". The FDA issued a decision of Substantially Equivalent on August 17, 2017. 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 17, 2017
Date Received
June 16, 2017
Clearance Type
Special
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