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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 K171455
Device Name AT-6XX Series Infrared Thermometer
Applicant
Xiamen Acurio Instruments Co., Ltd.
3rd-4th Floors, Bi Park, #2028
Wengjiao W. Rd., Haicang District
Xiamen,  CN 361026
Applicant Contact Angel Liu
Correspondent
Xiamen Acurio Instruments Co., Ltd.
3rd-4th Floors, Bi Park, #2028
Wengjiao W. Rd., Haicang District
Xiamen,  CN 361026
Correspondent Contact Angel Liu
Regulation Number880.2910
Classification Product Code
FLL  
Date Received05/17/2017
Decision Date 02/09/2018
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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