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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 K242721
Device Name Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131)
Applicant
Shenzhen Finicare Co., Ltd.
201, #50, The 3rd Industrial Park, Houting Community,
Shajing St., Bao'An District
Shenzhen,  CN 518104
Applicant Contact Li Chao
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm. 608, # 738 Shangcheng Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number870.1130
Classification Product Code
DXN  
Date Received09/10/2024
Decision Date 10/04/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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