Infrared Forehead Thermometer, FT-100A

Thermometer, Electronic, Clinical

HANGZHOU UNIVERSAL ELECTRONIC CO., LTD.

The following data is part of a premarket notification filed by Hangzhou Universal Electronic Co., Ltd. with the FDA for Infrared Forehead Thermometer, Ft-100a.

Pre-market Notification Details

Device IDK160802
510k NumberK160802
Device Name:Infrared Forehead Thermometer, FT-100A
ClassificationThermometer, Electronic, Clinical
Applicant HANGZHOU UNIVERSAL ELECTRONIC CO., LTD. 38 YANGJIATANG, SANDUN, WESTLAKE DISTRICT Hangzhou City,  CN 310030
ContactJiaqiang Wan
CorrespondentCharlie Mack
IRC 7808 RUSH CREEK DRIVE Pasco,  WA  99301
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-03-23
Decision Date2016-08-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860001625813 K160802 000
00049696731621 K160802 000

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