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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 K222994
Device Name Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B
Applicant
Shenzhen AOJ Medical Technology Co., Ltd.
Rm. 301 & 4f, Blk A, Bldg. A, Jingfa Im Park, Xiaweiyuan
Gushu Community, Xixiang, Baoan
Shenzhen,  CN 518126
Applicant Contact Jack Wang
Correspondent
Shenzhen AOJ Medical Technology Co., Ltd.
Rm. 301 & 4f, Blk A, Bldg. A, Jingfa Im Park, Xiaweiyuan
Gushu Community, Xixiang, Baoan
Shenzhen,  CN 518126
Correspondent Contact Jack Wang
Regulation Number870.1130
Classification Product Code
DXN  
Date Received09/28/2022
Decision Date 07/26/2023
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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