Cleared Traditional

GSI Audera Pro

K193033 · Grason Stadler · Neurology
Apr 2020
Decision
176d
Days
Class 2
Risk

About This 510(k) Submission

K193033 is an FDA 510(k) clearance for the GSI Audera Pro, a Stimulator, Auditory, Evoked Response (Class II — Special Controls, product code GWJ), submitted by Grason Stadler (Eden Prairie, US). The FDA issued a Cleared decision on April 24, 2020, 176 days after receiving the submission on October 31, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1900.

Submission Details

510(k) Number K193033 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 2019
Decision Date April 24, 2020
Days to Decision 176 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWJ — Stimulator, Auditory, Evoked Response
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1900