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510(k) K935348

ODYSSEY CLINICAL AUDIOMETER by Qualitone — Product Code EWO

K935348 is an FDA 510(k) premarket notification submitted by Qualitone for the device "ODYSSEY CLINICAL AUDIOMETER". The FDA issued a decision of Substantially Equivalent on February 9, 1994. The device falls under product code EWO (Audiometer), a Class II device regulated under 21 CFR 874.1050. Qualitone has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1994
Date Received
November 5, 1993
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 Qualitone

  • K961827 — IN-THE-EAR (July 3, 1996)
  • K955466 — DYNAMEQ-II OPTION (February 13, 1996)
  • K955359 — CYBER III OPTION UM, UC312, UC10, UCIC (December 19, 1995)
  • K953884 — PROPHET (October 27, 1995)
  • K941107 — THE CANAL (C.I.C.) AKA/HIDDEN EAR (August 9, 1994)
  • K935289 — PRO FIT-CYBER II OPTION (December 22, 1993)
  • K923006 — AS-90 (September 18, 1993)
  • K923007 — AT-2 (February 26, 1993)
  • K923986 — CYBERNETIC OPTION (CYBER I) (September 10, 1992)
  • K923013 — ACOUSTIC APPRAISE CD-3 (August 14, 1992)

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)

FDA data resources