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510(k) K030016

TEOAE25 by Interacoustics A/S, Assens — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2003
Date Received
January 2, 2003
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 Interacoustics A/S, Assens

  • K060539 — DPOAE20 , ECLIPSE (May 30, 2006)
  • K050496 — REM440 (April 29, 2005)
  • K022728 — AUDIOTRAVELLER, MODEL AA222 (October 11, 2002)

Other clearances for product code EWO

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  • 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)