INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE

Tube, Feeding

PHILIPS MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Innersense Esophageal Temperature Probe / Feeding Tube.

Pre-market Notification Details

Device IDK131590
510k NumberK131590
Device Name:INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE
ClassificationTube, Feeding
Applicant PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD Andover,  MA  01810
ContactChristine Trefethen
CorrespondentChristine Trefethen
PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD Andover,  MA  01810
Product CodeFPD  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-05-31
Decision Date2013-10-23
Summary:summary

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