510(k) K131394

TRANSTEK GLASS BODY FAT ANALYZER by Guangdong Transtek Medical Electronics Co., Ltd. — Product Code MNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2013
Date Received
May 15, 2013
Clearance Type
Special
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