C2 NERVEMONITOR SYSTEM WITH ACCESSORIES

Stimulator, Electrical, Evoked Response

INOMED MEDIZINTECHNIK GMBH

The following data is part of a premarket notification filed by Inomed Medizintechnik Gmbh with the FDA for C2 Nervemonitor System With Accessories.

Pre-market Notification Details

Device IDK111647
510k NumberK111647
Device Name:C2 NERVEMONITOR SYSTEM WITH ACCESSORIES
ClassificationStimulator, Electrical, Evoked Response
Applicant INOMED MEDIZINTECHNIK GMBH IM HAUSGRUEN 29 Emmendingen,  DE 79312
ContactSaschka Busch
CorrespondentSaschka Busch
INOMED MEDIZINTECHNIK GMBH IM HAUSGRUEN 29 Emmendingen,  DE 79312
Product CodeGWF  
CFR Regulation Number882.1870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-06-13
Decision Date2011-10-06
Summary:summary

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