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FDA 510(k)

Otoport Pro

K-Number: K240430 · 2024-03-15

ApplicantOtodynamics, Ltd.
Decision Date2024-03-15
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Otoport Pro is a medical device manufactured by Otodynamics, Ltd.. It received FDA 510(k) clearance on 2024-03-15 under approval 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. It is manufactured by Otodynamics, Ltd.. The 510(k) number is K240430.

When was Otoport Pro approved by the FDA?

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

What company makes Otoport Pro?

Otoport Pro is manufactured by Otodynamics, Ltd..

What is the FDA product code for Otoport Pro?

The FDA product code for Otoport Pro is EWO.

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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.

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