FDA 510(k)

Otoport Pro

K-Number: K240430 · 2024-03-15

Decision Date2024-03-15

Product CodeEWO

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

Otoport Pro is the device name listed in this FDA 510(k) record. The listed applicant is Otodynamics, Ltd.. It received FDA 510(k) clearance on 2024-03-15 under 510(k) number K240430. The device is classified under product code EWO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Otoport Pro?

Otoport Pro is a medical device that received FDA 510(k) clearance on 2024-03-15. The listed applicant is Otodynamics, Ltd.. The 510(k) number is K240430.

When did Otoport Pro receive FDA 510(k) clearance?

Otoport Pro received FDA 510(k) clearance on 2024-03-15, under 510(k) number K240430.

Who is the listed applicant for Otoport Pro?

The FDA 510(k) record lists Otodynamics, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Otoport Pro?

The FDA product code for Otoport Pro is EWO.

Other records listing Otodynamics, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K234095OtoNova/OtoNova Pro

Related Devices (Code: EWO)

K234095OtoNova/OtoNova ProOtodynamics K231545hearOAEHearx SA (Pty) , Ltd.K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEPath Medical GmbH K191372LyraInteracoustics A/S K180287GSI CortiGrason-Stadler, Inc.K173567SeraInteracoustics A/S

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.