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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 K231245
Device Name Digital Blood Pressure Monitor (Arm Type)
Applicant
Guangdong Genial Technology Co., Ltd.
I-6-05-02, 11th Rd., Area B, Guangfozhao Economic
Cooperation Zone,Zhagang Town, Huaiji Cou
Zhaoqing,  CN 526437
Applicant Contact Yu Jun
Correspondent
Shenzhen Reanny Medical Devices Management Consulting Co.Ltd
Rm. 1407, Jingting Bldg., Dongzhou Community, Guangming
St., Guangming District
Shenzhen,  CN 518000
Correspondent Contact Reanny Wang
Regulation Number870.1130
Classification Product Code
DXN  
Date Received05/01/2023
Decision Date 11/22/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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