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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K221039
Device Name Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y
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 Number880.2910
Classification Product Code
FLL  
Date Received04/07/2022
Decision Date 12/20/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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