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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 K213011
Device Name Infrared Thermometer (model: E201)
Applicant
Bioland Technology, Ltd.
# A6b7 (Block G) Shangrong Industrial Zone, # 5 Baolong
Rd.
Shenzhen,  CN 518116
Applicant Contact Wenjuan Xia
Correspondent
Bioland Technology, Ltd.
# A6b7 (Block G) Shangrong Industrial Zone, # 5 Baolong
Rd.
Shenzhen,  CN 518116
Correspondent Contact Eric Tan
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/20/2021
Decision Date 04/05/2022
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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