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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 K232815
Device Name Wrist Blood Pressure Monitor
Applicant
Zhuhai Yueja Medical Device Technology Co., Ltd.
Rm. 201, Bldg. 2, #2 Liushi Rd.,
Tangjiawan Town, High-Tech Zone
Zhuhai,  CN 519000
Applicant Contact Feng Yan
Correspondent
Zhuhai Yueja Medical Device Technology Co., Ltd.
Rm. 201, Bldg. 2, #2 Liushi Rd.,
Tangjiawan Town, High-Tech Zone
Zhuhai,  CN 519000
Correspondent Contact Feng Yan
Regulation Number870.1130
Classification Product Code
DXN  
Date Received09/13/2023
Decision Date 12/11/2023
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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