Braun Thermoscan PRO 6000 Ear Thermometer

Thermometer, Electronic, Clinical

KAZ USA, INC (A SUBSIDIARY OF HELEN OF TROY, INC)

The following data is part of a premarket notification filed by Kaz Usa, Inc (a Subsidiary Of Helen Of Troy, Inc) with the FDA for Braun Thermoscan Pro 6000 Ear Thermometer.

Pre-market Notification Details

Device IDK152748
510k NumberK152748
Device Name:Braun Thermoscan PRO 6000 Ear Thermometer
ClassificationThermometer, Electronic, Clinical
Applicant KAZ USA, INC (A SUBSIDIARY OF HELEN OF TROY, INC) 250 TURNPIKE ROAD Southborough,  MA  01772
ContactRaj Kasbekar
CorrespondentRaj Kasbekar
KAZ USA, INC (A SUBSIDIARY OF HELEN OF TROY, INC) 250 TURNPIKE ROAD Southborough,  MA  01772
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-09-23
Decision Date2016-03-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00328785760002 K152748 000
00732094325324 K152748 000
00732094325089 K152748 000
00732094309027 K152748 000
00732094309003 K152748 000
00732094325317 K152748 000
00732094314649 K152748 000

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