CONTACT EMG ROTATABLE 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 Contact Emg Rotatable Endotracheal Tube.

Pre-market Notification Details

Device IDK050162
510k NumberK050162
Device Name:CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE
ClassificationStimulator, Nerve
Applicant MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville,  FL  32216
ContactDavid S Dodd
CorrespondentDavid S Dodd
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 Received2005-01-25
Decision Date2005-03-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169789579 K050162 000
00643169789562 K050162 000
00643169789555 K050162 000
00763000745868 K050162 000
00763000745851 K050162 000
00763000745844 K050162 000

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