Cleared Traditional

OtoNova/OtoNova Pro

K234095 · Otodynamics · Ear, Nose, Throat
Jun 2024
Decision
178d
Days
Class 2
Risk

About This 510(k) Submission

K234095 is an FDA 510(k) clearance for the OtoNova/OtoNova Pro, a Audiometer (Class II — Special Controls, product code EWO), submitted by Otodynamics (Hatfield, Hertfordshire, GB). The FDA issued a Cleared decision on June 21, 2024, 178 days after receiving the submission on December 26, 2023. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1050.

Submission Details

510(k) Number K234095 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 2023
Decision Date June 21, 2024
Days to Decision 178 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code EWO — Audiometer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.1050