ER36 Series OAE Test System— 510(k) K150491

Name: FDA 510(k) clearance K150491
Creator: U.S. Food and Drug Administration
Published: 2015-03-26

Substantially Equivalent

Etymotic Research, Inc.

FDA 510(k) clearance K150491 for ER36 Series OAE Test System, Substantially Equivalent on 2015-03-26. Applicant: Etymotic Research, Inc.. Device class: 2.

Clearance details

Applicant: Etymotic Research, Inc.
Product code: Code EWO
Device class: Class 2
Regulation: 21 CFR 874.1050
Advisory panel: Ear, Nose, Throat
Date received: 2015-02-25
Decision date: 2015-03-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Elk Grove Village, IL, 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.