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510(k) K935348

ODYSSEY CLINICAL AUDIOMETER by Qualitone — Product Code EWO

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)

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  • K151025 — iHearTest (December 29, 2015)