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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 K200710
Device Name Infrared PT2L Digital No-Touch Thermometer
Applicant
Andon Health Co, Ltd.
#3 Jinping St., Yaan Rd., Nankai District
Tianjin,  CN 300190
Applicant Contact Liu Yi
Correspondent
Andon Health Co, Ltd.
#3 Jinping St., Yaan Rd., Nankai District
Tianjin,  CN 300190
Correspondent Contact Liu Yi
Regulation Number880.2910
Classification Product Code
FLL  
Date Received03/18/2020
Decision Date 10/01/2020
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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