Mapping Suction Probe

Stimulator, Nerve

Inomed Medizintechnik GmbH

The following data is part of a premarket notification filed by Inomed Medizintechnik Gmbh with the FDA for Mapping Suction Probe.

Pre-market Notification Details

Device IDK212164
510k NumberK212164
Device Name:Mapping Suction Probe
ClassificationStimulator, Nerve
Applicant inomed Medizintechnik GmbH Im Hausgruen 29 Emmendingen,  DE 79312
ContactAlexander Maier
CorrespondentShuofei Cheng
inomed Medizintechnik GmbH Im Hausgruen 29 Emmendingen,  DE 79312
Product CodeETN  
CFR Regulation Number874.1820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-12
Decision Date2022-11-11

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