Cleared Traditional

hearOAE

K231545 · Hearx SA (Pty) , Ltd. · Ear, Nose, Throat
Oct 2023
Decision
150d
Days
Class 2
Risk

About This 510(k) Submission

K231545 is an FDA 510(k) clearance for the hearOAE, a Audiometer (Class II — Special Controls, product code EWO), submitted by Hearx SA (Pty) , Ltd. (Pretoria, ZA). The FDA issued a Cleared decision on October 27, 2023, 150 days after receiving the submission on May 30, 2023. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1050.

Submission Details

510(k) Number K231545 FDA.gov
FDA Decision Cleared SESE
Date Received May 30, 2023
Decision Date October 27, 2023
Days to Decision 150 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