TYMPANIC TEMPERATURE PROBE WITH FOAM, MODEL M1024233; WITHOUT FOAM MODEL M1024237

Thermometer, Electronic, Clinical

GE HEALTHCARE

The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Tympanic Temperature Probe With Foam, Model M1024233; Without Foam Model M1024237.

Pre-market Notification Details

Device IDK061942
510k NumberK061942
Device Name:TYMPANIC TEMPERATURE PROBE WITH FOAM, MODEL M1024233; WITHOUT FOAM MODEL M1024237
ClassificationThermometer, Electronic, Clinical
Applicant GE HEALTHCARE 86 PILGRIM ROAD Needham,  MA  02492
ContactJoel C Kent
CorrespondentJoel C Kent
GE HEALTHCARE 86 PILGRIM ROAD Needham,  MA  02492
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-07-10
Decision Date2006-09-29
Summary:summary

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