DISPOSABLE TEMPERATURE, SKIN AND ESOPHAGEAL PROBES

Thermometer, Electronic, Clinical

GE HEALTHCARE

The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Disposable Temperature, Skin And Esophageal Probes.

Pre-market Notification Details

Device IDK051873
510k NumberK051873
Device Name:DISPOSABLE TEMPERATURE, SKIN AND ESOPHAGEAL PROBES
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 Received2005-07-11
Decision Date2005-09-20
Summary:summary

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