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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name thermometer, electronic, clinical
510(k) Number K200531
Device Name iHealth Infrared No-Touch Forehead Thermometer
Applicant
Andon Health Co., Ltd.
No. 3 Jin Ping Street,Ya An Road, Nankai District
tianjin,  CN 300190
Applicant Contact liu yi
Correspondent
Andon Health Co., Ltd.
No. 3 Jin Ping Street,Ya An Road, Nankai District
tianjin,  CN 300190
Correspondent Contact liu yi
Regulation Number880.2910
Classification Product Code
FLL  
Date Received03/02/2020
Decision Date 07/15/2020
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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