XOMED-TREACE EMG ENDOTRACHEAL TUBEEN

Stimulator, Nerve

XOMED-TREACE, INC.

The following data is part of a premarket notification filed by Xomed-treace, Inc. with the FDA for Xomed-treace Emg Endotracheal Tubeen.

Pre-market Notification Details

Device IDK925640
510k NumberK925640
Device Name:XOMED-TREACE EMG ENDOTRACHEAL TUBEEN
ClassificationStimulator, Nerve
Applicant XOMED-TREACE, INC. 6743 SOUTHPOINT DRIVE NORTH Jacksonville,  FL  32216 -0980
ContactTerry C Mcmahon
CorrespondentTerry C Mcmahon
XOMED-TREACE, INC. 6743 SOUTHPOINT DRIVE NORTH Jacksonville,  FL  32216 -0980
Product CodeETN  
CFR Regulation Number874.1820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-11-09
Decision Date1993-08-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169789548 K925640 000
20643169358816 K925640 000
20643169358809 K925640 000
20643169358793 K925640 000
20643169358786 K925640 000
20885074446091 K925640 000
20885074446060 K925640 000
00763000745837 K925640 000
00763000745820 K925640 000
20643169358823 K925640 000
20643169358830 K925640 000
00643169789531 K925640 000
00643169789524 K925640 000
00643169358775 K925640 000
00643169358768 K925640 000
00643169358751 K925640 000
00643169358737 K925640 000
00643169358713 K925640 000
00643169358690 K925640 000
00763000745813 K925640 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.