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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 K212598
Device Name iHealth infrared Ear thermometer PT5
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 Received08/16/2021
Decision Date 01/28/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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