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510(k) K923013

ACOUSTIC APPRAISE CD-3 by Qualitone — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1992
Date Received
June 22, 1992
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)
  • K935348 — ODYSSEY CLINICAL AUDIOMETER (February 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)

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  • 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)