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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 K200434
Device Name V20, V20a, AVSM3 SNF
Applicant
Mediana Co., Ltd.
132, Donghwagongdan-ro, Munmak-eup
Wonju-si,  KR 26365
Applicant Contact Dana Mun
Correspondent
International Regulatory Consultants
2950 E Lindrick Drive
Chandler,  AZ  85249
Correspondent Contact Charlie Mack
Regulation Number870.1130
Classification Product Code
DXN  
Subsequent Product Codes
DQA   FLL  
Date Received02/24/2020
Decision Date 10/09/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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