hearOAE— 510(k) K231545

Substantially Equivalent

Hearx SA (Pty) , Ltd.

FDA 510(k) clearance K231545 for hearOAE, Substantially Equivalent on 2023-10-27. Applicant: Hearx SA (Pty) , Ltd..

Clearance details

Applicant: Hearx SA (Pty) , Ltd.
Product code: Code EWO
Advisory panel: Ear, Nose, Throat
Date received: 2023-05-30
Decision date: 2023-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pretoria, ZA

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.