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510(k) K981460

CUB DIS II DPOAE MEASUREMENT SYSTEM by Mimosa Acoustics, Inc. — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1998
Date Received
April 23, 1998
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 Mimosa Acoustics, Inc.

  • K123624 — OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM (March 28, 2013)
  • K063338 — HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER (January 4, 2007)
  • K053216 — HEARID WIDEBAND MIDDLE EAR POWER ANALYZER (February 10, 2006)

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  • K191372 — Lyra (July 15, 2019)
  • K180287 — GSI Corti (May 11, 2018)
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  • K172403 — GSI Novus (October 20, 2017)
  • K171506 — Easyscreen (August 29, 2017)
  • K151025 — iHearTest (December 29, 2015)