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510(k) K053216

HEARID WIDEBAND MIDDLE EAR POWER ANALYZER by Mimosa Acoustics, Inc. — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 2006
Date Received
November 17, 2005
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)
  • K981460 — CUB DIS II DPOAE MEASUREMENT SYSTEM (May 20, 1998)

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