INFARED EAR THERMOMETER, MODEL TH8 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 Infared Ear Thermometer, Model Th8 Series.

Pre-market Notification Details

Device IDK011059
510k NumberK011059
Device Name:INFARED EAR THERMOMETER, MODEL TH8 SERIES
ClassificationThermometer, Electronic, Clinical
Applicant RADIANT INNOVATION, INC. 55 Northern Blvd. Suite 200 Great Neck,  NY  11021
ContactSusan D Goldstein-falk
CorrespondentSusan D Goldstein-falk
RADIANT INNOVATION, INC. 55 Northern Blvd. Suite 200 Great Neck,  NY  11021
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-04-06
Decision Date2001-09-17

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