Braun No Touch + Forehead NTF3000 Thermometer

Thermometer, Electronic, Clinical

Kaz USA, Inc., A Helen Of Troy Company

The following data is part of a premarket notification filed by Kaz Usa, Inc., A Helen Of Troy Company with the FDA for Braun No Touch + Forehead Ntf3000 Thermometer.

Pre-market Notification Details

Device IDK163516
510k NumberK163516
Device Name:Braun No Touch + Forehead NTF3000 Thermometer
ClassificationThermometer, Electronic, Clinical
Applicant Kaz USA, Inc., A Helen Of Troy Company 400 Donald Lynch Boulevard Suite 300 Marlborough,  MA  01752
ContactRajesh Kasbekar
CorrespondentRajesh Kasbekar
Kaz USA, Inc., A Helen Of Troy Company 400 Donald Lynch Boulevard Suite 300 Marlborough,  MA  01752
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-12-15
Decision Date2017-04-21
Summary:summary

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