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510(k) K193033

GSI Audera Pro by Grason Stadler — Product Code GWJ

K193033 is an FDA 510(k) premarket notification submitted by Grason Stadler for the device "GSI Audera Pro". The FDA issued a decision of Substantially Equivalent on April 24, 2020. The device falls under product code GWJ (Stimulator, Auditory, Evoked Response), a Class II device regulated under 21 CFR 882.1900.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2020
Date Received
October 31, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Auditory, Evoked Response
Device Class
Class II
Regulation Number
882.1900
Review Panel
NE
Submission Type

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  • K211147 — ALGO 7i (October 14, 2021)
  • K163326 — SmartEP (September 29, 2017)
  • K162037 — Eclipse with VEMP (March 23, 2017)
  • K143670 — ICS CHARTR EP 200 WITH VEMP (October 23, 2015)
  • K141446 — ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO H (August 22, 2014)
  • K132957 — MADSEN ACCUSCREEN TYPE 1077 (February 27, 2014)
  • K131141 — EARPROBE (June 27, 2013)

FDA data resources