ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress

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 Isis Headboxes, Isis Neurostimulator, Isis Xpert Plus, Isis Xpert, Isis Xpress.

Pre-market Notification Details

Device IDK212166
510k NumberK212166
Device Name:ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
ClassificationStimulator, Electrical, Evoked Response
Applicant inomed Medizintechnik GmbH Im Hausgruen 29 Emmendingen,  DE 79312
ContactTomasz Moszkowski
CorrespondentAlexander Maier
inomed Medizintechnik GmbH Im Hausgruen 29 Emmendingen,  DE 79312
Product CodeGWF  
Subsequent Product CodeETN
Subsequent Product CodeGWE
Subsequent Product CodeGWJ
Subsequent Product CodeGWQ
Subsequent Product CodeIKN
CFR Regulation Number882.1870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-12
Decision Date2022-01-07

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