510(k) K051675

BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZER by Biodynamics Corp. — Product Code MNW

K051675 is an FDA 510(k) premarket notification submitted by Biodynamics Corp. for the device "BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZER". The FDA issued a decision of Substantially Equivalent on March 16, 2006. The device falls under product code MNW (Analyzer, Body Composition), a Class II device regulated under 21 CFR 870.2770. Biodynamics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2006
Date Received
June 23, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Body Composition
Device Class
Class II
Regulation Number
870.2770
Review Panel
GU
Submission Type