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510(k) K234095

OtoNova/OtoNova Pro by Otodynamics — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2024
Date Received
December 26, 2023
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

  • K240430 — Otoport Pro (March 15, 2024)
  • K143395 — Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otoche (February 23, 2015)
  • 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

  • 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)
  • K150491 — ER36 Series OAE Test System (March 26, 2015)