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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 K244000
Device Name Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure Monitor (ARM-30Q);Arm Blood Pressure Monitor (ARM-30E+);
Applicant
Shenzhen AOJ Medical Technology Co., Ltd.
Rm. 301&4f, Block A, Bldg. A,Ingfa Intelligent Manafacturing
Park Xiaweiyuan,Gushu Community, Xixiang St. Bao'An District
Shenzhen,  CN 518126
Applicant Contact Jack Wang
Correspondent
Shenzhen AOJ Medical Technology Co., Ltd.
Rm. 301&4f, Block A, Bldg. A,Ingfa Intelligent Manafacturing
Park Xiaweiyuan,Gushu Community, Xixiang St. Bao'An District
Shenzhen,  CN 518126
Correspondent Contact Jack Wang
Regulation Number870.1130
Classification Product Code
DXN  
Date Received12/26/2024
Decision Date 04/30/2025
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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