UP-GRADE FOREHEAD THERMOMETER

Thermometer, Electronic, Clinical

MEDISIM LTD.

The following data is part of a premarket notification filed by Medisim Ltd. with the FDA for Up-grade Forehead Thermometer.

Pre-market Notification Details

Device IDK032362
510k NumberK032362
Device Name:UP-GRADE FOREHEAD THERMOMETER
ClassificationThermometer, Electronic, Clinical
Applicant MEDISIM LTD. THE TECHNOLOGY PARK MANHAT Jerusalem,  IL 96251
ContactDalia Givony
CorrespondentDalia Givony
MEDISIM LTD. THE TECHNOLOGY PARK MANHAT Jerusalem,  IL 96251
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-07-31
Decision Date2003-12-04
Summary:summary

NIH GUDID Devices

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