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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K123130
Device Name ANSWATCH WRIST MONITOR MODEL TS-0411
Applicant
Taiwan Scientific Corporation
10f, 88-4, Ming-Chiuan Rd.,
Shin-Dian Distric
New Taipei,  TW 23141
Applicant Contact DEHCHUAN SUN
Correspondent
Taiwan Scientific Corporation
10f, 88-4, Ming-Chiuan Rd.,
Shin-Dian Distric
New Taipei,  TW 23141
Correspondent Contact DEHCHUAN SUN
Regulation Number870.1130
Classification Product Code
DXN  
Date Received10/04/2012
Decision Date 09/17/2013
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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