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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 K193348
Device Name Blood Pressure Monitor
Applicant
Shenzhen Viatom Technology Co., Ltd.
4e, Bldg. 3, Tingwei Industrial Park, #6 Liufang Rd.
Block 67, Xin'An St., Baoan District
Shenzhen,  CN 518101
Applicant Contact Zhou Saixin
Correspondent
Shenzhen Viatom Technology Co., Ltd.
4205-4210#, Shenzhen International Chamber Of Commerce Tower
168#, Fuhua 3 Rd., Futian District
Shenzhen,  CN 518048
Correspondent Contact Lucy Yan
Regulation Number870.1130
Classification Product Code
DXN  
Subsequent Product Code
DPS  
Date Received12/03/2019
Decision Date 06/25/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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