INFRARED EAR THERMOMETER, MODELS TH88 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 Infrared Ear Thermometer, Models Th88 Series.

Pre-market Notification Details

Device IDK020504
510k NumberK020504
Device Name:INFRARED EAR THERMOMETER, MODELS TH88 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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-02-15
Decision Date2002-02-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50666519700012 K020504 000

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