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EWO

Audiometer

Product code
EWO
Device name
Audiometer
Device class
Class 2
21 CFR
21 CFR 874.1050
Medical specialty
Ear, Nose, Throat
Marketing pathway
510(K) Exempt
510(k) clearances (last 3 years)
3
Summaries archived here
3 (direct download)
510(k) clearances (all years, FDA)
235 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2024-06-21.

NumberDecision dateApplicantDevice nameSummary
K2340952024-06-21OtodynamicsOtoNova/OtoNova ProPDF
K2404302024-03-15Otodynamics, Ltd.Otoport ProPDF
K2315452023-10-27Hearx SA (Pty) , Ltd.hearOAEPDF

3 summaries are archived here for direct download.

Official FDA classification page: EWO
Classification and pathway per current FDA publications. Data from openFDA (CC0).