ZMI Self-Adhesive Electrodes— 510(k) K180865

Substantially Equivalent

Zmi Electronics , Ltd.

FDA 510(k) clearance K180865 for ZMI Self-Adhesive Electrodes, Substantially Equivalent on 2018-06-28. Applicant: Zmi Electronics , Ltd.. Device class: 2.

Clearance details

Applicant
Zmi Electronics , 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
Kaohsiung, TW
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