AViTA Radar Thermo NT16 Series IR Thermometer

Thermometer, Electronic, Clinical

Avita Corporation

The following data is part of a premarket notification filed by Avita Corporation with the FDA for Avita Radar Thermo Nt16 Series Ir Thermometer.

Pre-market Notification Details

Device IDK172427
510k NumberK172427
Device Name:AViTA Radar Thermo NT16 Series IR Thermometer
ClassificationThermometer, Electronic, Clinical
Applicant Avita Corporation 9F, No.78, Sec. 1, Kwang-Fu Road., San-Chung District New Taipei City,  TW 24158
ContactSteven Jhou
CorrespondentSteven Jhou
Avita Corporation 9F, No.78, Sec. 1, Kwang-Fu Road., San-Chung District New Taipei City,  TW 24158
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-08-10
Decision Date2018-04-19
Summary:summary

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