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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 K211629
Device Name Infrared forehead thermometer LD-FT-100B
Applicant
Honsun (Nantong) Co., Ltd.
#8, Tongxing Rd.
Nantong Economic & Technological Development Area
Nanton,  CN 226009
Applicant Contact Iris Du
Correspondent
Honsun (Nantong) Co., Ltd.
#8, Tongxing Rd.
Nantong Economic & Technological Development Area
Nanton,  CN 226009
Correspondent Contact Iris Du
Regulation Number880.2910
Classification Product Code
FLL  
Date Received05/27/2021
Decision Date 12/08/2021
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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