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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 K211744
Device Name Non-Contact Infrared Thermometer, model HL710H
Applicant
Health & Life Co., Ltd.
9f, # 186, Jian Yi Rd. Zhonghe District
New Taipei,  TW 23553
Applicant Contact Simon Lee
Correspondent
Health & Life Co., Ltd.
9f, # 186, Jian Yi Rd. Zhonghe District
New Taipei,  TW 23553
Correspondent Contact Melody Jiang
Regulation Number880.2910
Classification Product Code
FLL  
Date Received06/07/2021
Decision Date 11/24/2021
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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