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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K172965
Device Name Handheld VitalSigns Monitoring System
Applicant
Visiomed Technology Co.,Ltd
2 Floor Of #1 Bldg.,
Jia An Technological Industial Park, 67 District,
Bao An, Shenzhen,,  CN 518000
Applicant Contact Chen XiaoFeng
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1122#, International Mayor Communication Center,
Baishizhong Rd. 55#
Nanshan District, Shenzhen,  CN 518000
Correspondent Contact Filed Fu
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Codes
DQA   DRT   DXN   FLL  
Date Received09/26/2017
Decision Date 12/17/2018
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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