RII INFRARED EAR THERMOMETER, MODEL: TH60N

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, Model: Th60n.

Pre-market Notification Details

Device IDK101253
510k NumberK101253
Device Name:RII INFRARED EAR THERMOMETER, MODEL: TH60N
ClassificationThermometer, Electronic, Clinical
Applicant RADIANT INNOVATION INC. 1F, NO. 3 INDUSTRIAL E. 9TH RD SCIENCE-BASED INDUSTRIAL PARK, Hsin Chu,  TW
ContactJames Huang
CorrespondentJames Huang
RADIANT INNOVATION INC. 1F, NO. 3 INDUSTRIAL E. 9TH RD SCIENCE-BASED INDUSTRIAL PARK, Hsin Chu,  TW
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-05-04
Decision Date2010-06-29
Summary:summary

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