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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Thermometer, Electronic, Clinical
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
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