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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 K201600
Device Name Infrared thermometer, models KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26, KFT-27, KFT-28
Applicant
Kangfu Medical Equipment Factory
#380 Ningkang E. Rd., Lecheng Town, Yueqing
Wenzhou,  CN 325699
Applicant Contact Jixiang Zhang
Correspondent
Kangfu Medical Equipment Factory
#380 Ningkang E. Rd., Lecheng Town, Yueqing
Wenzhou,  CN 325699
Correspondent Contact Jixiang Zhang
Regulation Number880.2910
Classification Product Code
FLL  
Date Received06/12/2020
Decision Date 12/10/2021
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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