NERVE INTEGRITY MONITOR-2 (NIM-2 XL)

Stimulator, Nerve

XOMED-TREACE, INC.

The following data is part of a premarket notification filed by Xomed-treace, Inc. with the FDA for Nerve Integrity Monitor-2 (nim-2 Xl).

Pre-market Notification Details

Device IDK934426
510k NumberK934426
Device Name:NERVE INTEGRITY MONITOR-2 (NIM-2 XL)
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 Received1993-09-10
Decision Date1994-05-13

NIH GUDID Devices

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