AVITA TSO/TS1 INFRARED EAR THERMOMETER

Thermometer, Electronic, Clinical

AVITA CORPORATION

The following data is part of a premarket notification filed by Avita Corporation with the FDA for Avita Tso/ts1 Infrared Ear Thermometer.

Pre-market Notification Details

Device IDK002182
510k NumberK002182
Device Name:AVITA TSO/TS1 INFRARED EAR THERMOMETER
ClassificationThermometer, Electronic, Clinical
Applicant AVITA CORPORATION 900 N. SWITZER CANYON DR. #142 Flaggstaff,  AZ  86001
ContactAllen Reich
CorrespondentAllen Reich
AVITA CORPORATION 900 N. SWITZER CANYON DR. #142 Flaggstaff,  AZ  86001
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-07-19
Decision Date2000-12-29

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