Cleared Special

Otoport Pro

K240430 · Otodynamics, Ltd. · Ear, Nose, Throat
Mar 2024
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K240430 is an FDA 510(k) clearance for the Otoport Pro, a Audiometer (Class II — Special Controls, product code EWO), submitted by Otodynamics, Ltd. (Hatfield, Hertfordshire, GB). The FDA issued a Cleared decision on March 15, 2024, 30 days after receiving the submission on February 14, 2024. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1050.

Submission Details

510(k) Number K240430 FDA.gov
FDA Decision Cleared SESE
Date Received February 14, 2024
Decision Date March 15, 2024
Days to Decision 30 days
Submission Type Special
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