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510(k) K063338

HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER by Mimosa Acoustics, Inc. — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 2007
Date Received
November 6, 2006
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.

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  • K053216 — HEARID WIDEBAND MIDDLE EAR POWER ANALYZER (February 10, 2006)
  • K981460 — CUB DIS II DPOAE MEASUREMENT SYSTEM (May 20, 1998)

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  • K191372 — Lyra (July 15, 2019)
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  • K173567 — Sera (February 14, 2018)
  • K172403 — GSI Novus (October 20, 2017)
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  • K151025 — iHearTest (December 29, 2015)