Adhesive Electrodes— 510(k) K160138

Substantially Equivalent

Gmdasz Manufacturing Co., Ltd.

FDA 510(k) clearance K160138 for Adhesive Electrodes, Substantially Equivalent on 2016-08-11. Applicant: Gmdasz Manufacturing Co., Ltd.. Device class: 2.

Clearance details

Applicant
Gmdasz Manufacturing Co., Ltd.
Product code
Code GXY
Device class
Class 2
Regulation
21 CFR 882.1320
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Shenzhen City, CN
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