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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 K230566
Device Name Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor
Applicant
Joytech Healthcare Co. , Ltd.
#365, Wuzhou Rd.
Yuhang Economic Development Zone, Hangzhou City
Hangzhou,  CN 311100
Applicant Contact Ren Yunhua
Correspondent
Joytech Healthcare Co. , Ltd.
#365, Wuzhou Rd.
Yuhang Economic Development Zone, Hangzhou City
Hangzhou,  CN 311100
Correspondent Contact Ren Yunhua
Regulation Number870.1130
Classification Product Code
DXN  
Date Received03/01/2023
Decision Date 08/25/2023
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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