TEOAE25— 510(k) K030016

Substantially Equivalent

Interacoustics A/S, Assens

FDA 510(k) clearance K030016 for TEOAE25, Substantially Equivalent on 2003-03-28. Applicant: Interacoustics A/S, Assens.

Clearance details

Applicant: Interacoustics A/S, Assens
Product code: Code EWO
Advisory panel: Ear, Nose, Throat
Date received: 2003-01-02
Decision date: 2003-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, 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.