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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K162665
Device Name MiCor A100 Wearable ECG Recorder
Applicant
Mitac International Corp.
# 200, Wen Hua 2nd Rd., Guishan Dist.
Taoyuan City,  TW 33383
Applicant Contact YIHAO HUANG
Correspondent
Mitac International Corp.
# 200, Wen Hua 2nd Rd., Guishan Dist.
Taoyuan City,  TW 33383
Correspondent Contact YIHAO HUANG
Regulation Number870.2340
Classification Product Code
DPS  
Date Received09/26/2016
Decision Date 01/26/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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