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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 K220651
Device Name Wrist Type Blood Pressure Monitor
Applicant
Shenzhen Jamr Medical Technology Co., Ltd.
A101-301, D101-201, Jamr Science & Technology Park, #2
Guiyuan Rd., Guixiang Community
Shenzhen,  CN 518100
Applicant Contact Luo Fusheng
Correspondent
Shenzhen Reanny Medical Devices Management Consulting Co., Ltd.
Rm. 2012#, Gebu Commercial Bldg., Hongxing Community,
Songgang St.
Shenzhen,  CN 518000
Correspondent Contact Reanny Wang
Regulation Number870.1130
Classification Product Code
DXN  
Date Received03/07/2022
Decision Date 06/30/2022
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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