AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION— 510(k) K111618

Name: FDA 510(k) clearance K111618
Creator: U.S. Food and Drug Administration
Published: 2011-12-28

Substantially Equivalent

Natus Medical Incorporated

FDA 510(k) clearance K111618 for AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION, Substantially Equivalent on 2011-12-28. Applicant: Natus Medical Incorporated. Device class: 2.

Clearance details

Applicant: Natus Medical Incorporated
Product code: Code EWO
Device class: Class 2
Regulation: 21 CFR 874.1050
Advisory panel: Ear, Nose, Throat
Date received: 2011-06-10
Decision date: 2011-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

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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.