ETYMOTIC RESEARCH ER-10D OAE PROBE— 510(k) K011114

Substantially Equivalent

Etymotic Research

FDA 510(k) clearance K011114 for ETYMOTIC RESEARCH ER-10D OAE PROBE, Substantially Equivalent on 2001-07-03. Applicant: Etymotic Research.

Clearance details

Applicant: Etymotic Research
Product code: Code EWO
Advisory panel: Ear, Nose, Throat
Date received: 2001-04-12
Decision date: 2001-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elk Grove Village, IL, US

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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.