MICROLIFE DIGITAL INFRARED FOREHEAD THERMOMETER, MODEL FR1DM1

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 Forehead Thermometer, Model Fr1dm1.

Pre-market Notification Details

Device IDK033820
510k NumberK033820
Device Name:MICROLIFE DIGITAL INFRARED FOREHEAD THERMOMETER, MODEL FR1DM1
ClassificationThermometer, Electronic, Clinical
Applicant MICROLIFE INTELLECTUAL PROPERTY GMBH 55 NORTHERN BLVD., SUITE 200 Great Neck,  NY  11021
ContactSusan D Goldstein-falk
CorrespondentSusan D Goldstein-falk
MICROLIFE INTELLECTUAL PROPERTY GMBH 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 Received2003-12-09
Decision Date2004-02-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00328785000627 K033820 000
00328785000412 K033820 000
10328785004899 K033820 000

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