ILO292 DP ECHOPORT PLUS OAE SYSTEM— 510(k) K983351

Substantially Equivalent

Otodynamics, Ltd.

FDA 510(k) clearance K983351 for ILO292 DP ECHOPORT PLUS OAE SYSTEM, Substantially Equivalent on 1998-12-11. Applicant: Otodynamics, Ltd..

Clearance details

Applicant: Otodynamics, Ltd.
Product code: Code EWO
Advisory panel: Ear, Nose, Throat
Date received: 1998-09-23
Decision date: 1998-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crofton, MD, 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.