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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 K231367
Device Name Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221)
Applicant
Shenzhen Finicare Co., Ltd.
201, #50, The 3rd Industrial Park, Houting Community
Shajing St., Bao'An District
Shenzhen,  CN 518104
Applicant Contact Chao Li
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm.1801,#161,East Lu Jiazui Rd.,Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number870.1130
Classification Product Code
DXN  
Date Received05/11/2023
Decision Date 09/18/2023
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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