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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 K252501
Device Name Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L)
Applicant
Joytech Healthcare Co. , Ltd.
#365, Wuzhou Rd.
#502, Shunda Rd.
Hangzhou,  CN 311100
Applicant Contact Jing Cong
Correspondent
Joytech Healthcare Co. , Ltd.
#365, Wuzhou Rd.
#502, Shunda Rd.
Hangzhou,  CN 311100
Correspondent Contact Chaojie Guo
Regulation Number870.1130
Classification Product Code
DXN  
Date Received08/08/2025
Decision Date 04/28/2026
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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