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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 K200531
Device Name iHealth Infrared No-Touch Forehead Thermometer
Applicant
Andon Health Co, Ltd.
# 3 Jin Ping St.,Ya An Rd.
Nankai District
Tianjin,  CN 300190
Applicant Contact Liu Yi
Correspondent
Andon Health Co, Ltd.
# 3 Jin Ping St.,Ya An Rd.
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
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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