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510(k) K132957

MADSEN ACCUSCREEN TYPE 1077 by Gn Otometrics — Product Code GWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2014
Date Received
September 20, 2013
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

Other clearances by Gn Otometrics

  • K161707 — Madsen Zodiac (September 1, 2016)
  • K151504 — ICS Impulse (November 16, 2015)
  • K143670 — ICS CHARTR EP 200 WITH VEMP (October 23, 2015)
  • K122550 — ICS IMPULSE (February 1, 2013)
  • K122028 — AURICAL HIT (October 23, 2012)
  • K122067 — TYPE 1077 ACCUSCREEN (September 27, 2012)
  • K110286 — GN OTOMETRICS TYPE 1053 FREEFIT (April 28, 2011)
  • K092373 — ICS CHARTR EP 200 (September 3, 2009)
  • K083399 — ICS CHARTR EP 200 (February 20, 2009)
  • K081234 — GN OTOMETRICS INSERT EARPHONES (July 14, 2008)

Other clearances for product code GWJ

  • K242954 — Integrity V500 (Integrity, Integrity with VEMP) (December 19, 2024)
  • K233649 — ALGO Pro Newborn Hearing Screener (ALGO Pro) (March 8, 2024)
  • K220139 — QScreen (August 3, 2022)
  • K211147 — ALGO 7i (October 14, 2021)
  • K193033 — GSI Audera Pro (April 24, 2020)
  • 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)
  • K131141 — EARPROBE (June 27, 2013)