The Braun ThermoScan® 3 High Speed Compact Ear 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 The Braun Thermoscan® 3 High Speed Compact Ear Thermometer.

Pre-market Notification Details

Device IDK161933
510k NumberK161933
Device Name:The Braun ThermoScan® 3 High Speed Compact Ear Thermometer
ClassificationThermometer, Electronic, Clinical
Applicant Kaz USA, Inc., A Helen Of Troy Company 400 DONALD LYNCH BLVD., SUITE 300 Marlborough,  MA  01752
ContactAmy Liu
CorrespondentAmy Liu
Kaz USA, Inc., A Helen Of Troy Company 400 DONALD LYNCH BLVD., SUITE 300 Marlborough,  MA  01752
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-07-14
Decision Date2016-08-16
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.