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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 K201879
Device Name Digital Thermometer Model T103, T104
Applicant
Bioland Technology, Ltd.
# A6b7 (Block G) Shangrong Industrial Zone # 5 Baolong R
Shenzhen,  CN 518116
Applicant Contact Yiqing Feng
Correspondent
Bioland Technology, Ltd.
# A6b7 (Block G) Shangrong Industrial Zone # 5 Baolong R
Shenzhen,  CN 518116
Correspondent Contact Yiqing Feng
Regulation Number880.2910
Classification Product Code
FLL  
Date Received07/07/2020
Decision Date 03/31/2021
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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