510(k) K112149

WEIGHT AND BODY FAT SCALE SHINE BS0105 by Shine Overseas Marketing Limited — Product Code MNW

K112149 is an FDA 510(k) premarket notification submitted by Shine Overseas Marketing Limited for the device "WEIGHT AND BODY FAT SCALE SHINE BS0105". The FDA issued a decision of Substantially Equivalent on April 9, 2012. The device falls under product code MNW (Analyzer, Body Composition), a Class II device regulated under 21 CFR 870.2770.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 2012
Date Received
July 26, 2011
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