RII INFRARED EAR THERMOMETER, MODELS TH5XY SERIES

Thermometer, Electronic, Clinical

RADIANT INNOVATION, INC.

The following data is part of a premarket notification filed by Radiant Innovation, Inc. with the FDA for Rii Infrared Ear Thermometer, Models Th5xy Series.

Pre-market Notification Details

Device IDK063185
510k NumberK063185
Device Name:RII INFRARED EAR THERMOMETER, MODELS TH5XY SERIES
ClassificationThermometer, Electronic, Clinical
Applicant RADIANT INNOVATION, INC. 1F,NO. 3,INDUSTRIAL E. 9TH RD SCIENCE-BASED INDUSTRIAL PARK Hsinchu,  TW 300
ContactFrank Lin
CorrespondentFrank Lin
RADIANT INNOVATION, INC. 1F,NO. 3,INDUSTRIAL E. 9TH RD SCIENCE-BASED INDUSTRIAL PARK Hsinchu,  TW 300
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-10-20
Decision Date2006-11-17
Summary:summary

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