NON-CONTACT CLINICAL THERMOMETER

Thermometer, Electronic, Clinical

RADIANT INNOVATION INC.

The following data is part of a premarket notification filed by Radiant Innovation Inc. with the FDA for Non-contact Clinical Thermometer.

Pre-market Notification Details

Device IDK121428
510k NumberK121428
Device Name:NON-CONTACT CLINICAL THERMOMETER
ClassificationThermometer, Electronic, Clinical
Applicant RADIANT INNOVATION INC. 1F, NO.3, INDUSTRIAL E. 9TH RD SCIENCE-BASED INDUSTRIAL PARK Hsinchu,  TW 30075
ContactJames Huang
CorrespondentJames Huang
RADIANT INNOVATION INC. 1F, NO.3, INDUSTRIAL E. 9TH RD SCIENCE-BASED INDUSTRIAL PARK Hsinchu,  TW 30075
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-05-14
Decision Date2012-07-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884392626024 K121428 000
50666519700036 K121428 000
10860003705305 K121428 000
00194484319427 K121428 000
00860003705315 K121428 000
00840177900006 K121428 000
00073796507206 K121428 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.