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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 K002182
Device Name AVITA TSO/TS1 INFRARED EAR THERMOMETER
Applicant
Avita Corporation
900 N. Switzer Canyon Dr. #142
Flaggstaff,  AZ  86001
Applicant Contact ALLEN REICH
Correspondent
Avita Corporation
900 N. Switzer Canyon Dr. #142
Flaggstaff,  AZ  86001
Correspondent Contact ALLEN REICH
Regulation Number880.2910
Classification Product Code
FLL  
Date Received07/19/2000
Decision Date 12/29/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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