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510(k) K060539

DPOAE20 , ECLIPSE by Interacoustics A/S, Assens — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2006
Date Received
March 1, 2006
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

  • K050496 — REM440 (April 29, 2005)
  • K030016 — TEOAE25 (March 28, 2003)
  • K022728 — AUDIOTRAVELLER, MODEL AA222 (October 11, 2002)

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  • 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)