MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IRIDVI-1

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, Model Iridvi-1.

Pre-market Notification Details

Device IDK091040
510k NumberK091040
Device Name:MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IRIDVI-1
ClassificationThermometer, Electronic, Clinical
Applicant MICROLIFE INTELLECTUAL PROPERTY GMBH MDI CONSULTANTS, INC. 55 NORTHERN BLVD., SUITE 200 Great Neck,  NY  11021
ContactSusan Goldstein-falk
CorrespondentSusan Goldstein-falk
MICROLIFE INTELLECTUAL PROPERTY GMBH 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 Received2009-04-13
Decision Date2009-05-13
Summary:summary

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