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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K180865
Device Name ZMI Self-Adhesive Electrodes
Applicant
Zmi Electronics , Ltd.
6f-1, 286-4, Shin Ya Rd.
Kaohsiung,  TW 806
Applicant Contact Wayne Chen
Correspondent
Zmi Electronics , Ltd.
6f-1, 286-4, Shin Ya Rd.
Kaohsiung,  TW 806
Correspondent Contact Yuta Lee
Regulation Number882.1320
Classification Product Code
GXY  
Date Received04/02/2018
Decision Date 06/28/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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