EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE— 510(k) K090406

Substantially Equivalent

Interacoustics AS

FDA 510(k) clearance K090406 for EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE, Substantially Equivalent on 2009-07-22. Applicant: Interacoustics AS.

Clearance details

Applicant: Interacoustics AS
Product code: Code EWO
Advisory panel: Ear, Nose, Throat
Date received: 2009-02-17
Decision date: 2009-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Assens, DK

Download summary PDF View on FDA.gov ↗

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.