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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 K213023
Device Name Blood Pressure Monitor(Model:Y30001)
Applicant
Zhangzhou Easepal Medical Science and Technology Co., Ltd.
West Of The 4th Floor,No7. Bldg.,Easepal Factory,
#228, Jiaosong Rd., Jiaomei Town
Zhangzhou,  CN 363000
Applicant Contact Yuehua Huang
Correspondent
Guangdong Jianda Medical Technology Co., Ltd.
906 Rm., Longxiang Garden,
Tianhe District
Guangzhou,  CN 510000
Correspondent Contact Jett Lee
Regulation Number870.1130
Classification Product Code
DXN  
Date Received09/21/2021
Decision Date 09/30/2022
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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