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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 K170497
Device Name V10
Applicant
Mediana Co., Ltd.
132, Donghwagongdan-Ro, Munmak-Eup
Wonju-Si,  KR 220-801
Applicant Contact Kim Min-hye
Correspondent
International Regulatory Consulatants
7808 Rush Creek Dr.
Pasco,  WA  99301
Correspondent Contact Charlie Mack
Regulation Number870.1130
Classification Product Code
DXN  
Subsequent Product Codes
DQA   FLL  
Date Received02/17/2017
Decision Date 12/15/2017
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
Recalls CDRH Recalls
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