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510(k) K123624

OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM by Mimosa Acoustics, Inc. — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2013
Date Received
November 23, 2012
Clearance Type
Special
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.

  • K063338 — HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER (January 4, 2007)
  • K053216 — HEARID WIDEBAND MIDDLE EAR POWER ANALYZER (February 10, 2006)
  • K981460 — CUB DIS II DPOAE MEASUREMENT SYSTEM (May 20, 1998)

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