Braun BNT400 No Touch + Forehead 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 Bnt400 No Touch + Forehead Thermometer.

Pre-market Notification Details

Device IDK181242
510k NumberK181242
Device Name:Braun BNT400 No Touch + Forehead Thermometer
ClassificationThermometer, Electronic, Clinical
Applicant Kaz USA, Inc., A Helen Of Troy Company 400 Donald Lynch Boulevard, Suite 300 Marlborough,  MA  01752
ContactMatt J. Baun
CorrespondentMatt J. Baun
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 Received2018-05-10
Decision Date2018-07-23
Summary:summary

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