Microlife Digital Infrared Ear Thermometer

Thermometer, Electronic, Clinical

MICROLIFE INTELLECTUAL PROPERTY GMBH

The following data is part of a premarket notification filed by Microlife Intellectual Property Gmbh with the FDA for Microlife Digital Infrared Ear Thermometer.

Pre-market Notification Details

Device IDK170219
510k NumberK170219
Device Name:Microlife Digital Infrared Ear Thermometer
ClassificationThermometer, Electronic, Clinical
Applicant MICROLIFE INTELLECTUAL PROPERTY GMBH ESPENSTRASSE 139 Widnau,  CH 9443
ContactGerhard Frick
CorrespondentSusan D. Goldstein-falk
MDI CONSULTANTS, INC. 55 NORTHERN BLVD SUITE 200 Great Neck,  NY  11021
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-01-25
Decision Date2017-07-20
Summary:summary

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