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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 K252685
Device Name Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P)
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 Jing Cong
Regulation Number870.1130
Classification Product Code
DXN  
Date Received08/26/2025
Decision Date 02/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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