Home / 510(k) Clearances / K143395

510(k) K143395

Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit by Otodynamics, Ltd. — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2015
Date Received
November 26, 2014
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 Otodynamics, Ltd.

  • K234095 — OtoNova/OtoNova Pro (June 21, 2024)
  • K240430 — Otoport Pro (March 15, 2024)
  • K072033 — OTODYNAMICS OTOPORT (November 13, 2007)
  • K983351 — ILO292 DP ECHOPORT PLUS OAE SYSTEM (December 11, 1998)
  • K983350 — ILO292 DP ECHOPORT PLUS OAE SYSTEM (December 11, 1998)
  • K983352 — ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK (December 11, 1998)
  • K962995 — ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC (January 10, 1997)

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)