510(k) K132588

ADHESIVE ELECTRODES by Top-Rank Health Care Equipment Co., Ltd. — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2013
Date Received
August 19, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Cutaneous
Device Class
Class II
Regulation Number
882.1320
Review Panel
NE
Submission Type