510(k) K122976

BODY FAT SCALE MODEL SF-371 by Shenzhen Belter Health Measurement and Analysis TE — Product Code MNW

K122976 is an FDA 510(k) premarket notification submitted by Shenzhen Belter Health Measurement and Analysis TE for the device "BODY FAT SCALE MODEL SF-371". The FDA issued a decision of Substantially Equivalent on January 4, 2013. The device falls under product code MNW (Analyzer, Body Composition), a Class II device regulated under 21 CFR 870.2770. Shenzhen Belter Health Measurement and Analysis TE has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 2013
Date Received
September 26, 2012
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