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 IDK183663
510k NumberK183663
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-27
Decision Date2019-07-16

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