OtoNova/OtoNova Pro— 510(k) K234095

Substantially Equivalent

Otodynamics

FDA 510(k) clearance K234095 for OtoNova/OtoNova Pro, Substantially Equivalent on 2024-06-21. Applicant: Otodynamics.

Clearance details

Applicant: Otodynamics
Product code: Code EWO
Advisory panel: Ear, Nose, Throat
Date received: 2023-12-26
Decision date: 2024-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hatfield, Hertfordshire, GB

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.