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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 K201161
Device Name Infrared Thermometer Model E127
Applicant
Bioland Technology Ltd.
No. A6B7 (Block G), ShangRong Industrial Zone
No. 5 Baolong Road
Shenzhen,  CN 518116
Applicant Contact Yiqing Feng
Correspondent
Bioland Technology Ltd.
No. A6B7 (Block G), ShangRong Industrial Zone
No. 5 Baolong Road
Shenzhen,  CN 518116
Correspondent Contact Yiqing Feng
Regulation Number880.2910
Classification Product Code
FLL  
Date Received04/30/2020
Decision Date 10/02/2020
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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