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510(k) K081234

GN OTOMETRICS INSERT EARPHONES by Gn Otometrics — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2008
Date Received
May 1, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Audiometer
Device Class
Class II
Regulation Number
874.1050
Review Panel
EN
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)
  • K132957 — MADSEN ACCUSCREEN TYPE 1077 (February 27, 2014)
  • 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)

Other clearances for product code EWO

  • K234095 — OtoNova/OtoNova Pro (June 21, 2024)
  • K240430 — Otoport Pro (March 15, 2024)
  • K231545 — hearOAE (October 27, 2023)
  • K213345 — Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, Na (June 22, 2022)
  • K191372 — Lyra (July 15, 2019)
  • K180287 — GSI Corti (May 11, 2018)
  • K173567 — Sera (February 14, 2018)
  • K172403 — GSI Novus (October 20, 2017)
  • K171506 — Easyscreen (August 29, 2017)
  • K151025 — iHearTest (December 29, 2015)