NEXT GEN EMG ENDOTRACHEAL TUBE

Stimulator, Nerve

MEDTRONIC XOMED, INC.

The following data is part of a premarket notification filed by Medtronic Xomed, Inc. with the FDA for Next Gen Emg Endotracheal Tube.

Pre-market Notification Details

Device IDK112686
510k NumberK112686
Device Name:NEXT GEN EMG ENDOTRACHEAL TUBE
ClassificationStimulator, Nerve
Applicant MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville,  FL  32216
ContactMarek Pawlowski
CorrespondentMarek Pawlowski
MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville,  FL  32216
Product CodeETN  
CFR Regulation Number874.1820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-09-15
Decision Date2012-06-27
Summary:summary

NIH GUDID Devices

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