GSI Audera Pro

Stimulator, Auditory, Evoked Response

Grason Stadler

The following data is part of a premarket notification filed by Grason Stadler with the FDA for Gsi Audera Pro.

Pre-market Notification Details

Device IDK193033
510k NumberK193033
Device Name:GSI Audera Pro
ClassificationStimulator, Auditory, Evoked Response
Applicant Grason Stadler 10395 West 70th Street Eden Prairie,  MN  55344
ContactBrent Nissly
CorrespondentDaniel Kamm
Kamm & Associates 8870 Ravello Ct. Naples,  FL  34114
Product CodeGWJ  
CFR Regulation Number882.1900 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-31
Decision Date2020-04-24

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