OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM— 510(k) K123624

Name: FDA 510(k) clearance K123624
Creator: U.S. Food and Drug Administration
Published: 2013-03-28

Substantially Equivalent

Mimosa Acoustics, Inc.

FDA 510(k) clearance K123624 for OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM, Substantially Equivalent on 2013-03-28. Applicant: Mimosa Acoustics, Inc.. Device class: 2.

Clearance details

Applicant: Mimosa Acoustics, Inc.
Product code: Code EWO
Device class: Class 2
Regulation: 21 CFR 874.1050
Advisory panel: Ear, Nose, Throat
Date received: 2012-11-23
Decision date: 2013-03-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Champaign, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Mimosa Acoustics, Inc.

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K063338 — HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER2007-01-04
K053216 — HEARID WIDEBAND MIDDLE EAR POWER ANALYZER2006-02-10
K981460 — CUB DIS II DPOAE MEASUREMENT SYSTEM1998-05-20

Adverse events under product code EWO

product code EWO

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.