RII Multi-function Infrared Thermometer, Model TH52Z

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 Multi-function Infrared Thermometer, Model Th52z.

Pre-market Notification Details

Device IDK162083
510k NumberK162083
Device Name:RII Multi-function Infrared Thermometer, Model TH52Z
ClassificationThermometer, Electronic, Clinical
Applicant Radiant Innovation Inc. 1F, No.3 Industrial E. 9th Rd. Science-Based, Industrial Park Hsinchu,  TW 30075
ContactMonica Chung
CorrespondentMonica Chung
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 Received2016-07-27
Decision Date2017-01-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00810025921088 K162083 000

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