FDA 510(k)

OtoNova/OtoNova Pro

K-Number: K234095 · 2024-06-21

Decision Date2024-06-21

Product CodeEWO

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

OtoNova/OtoNova Pro is the device name listed in this FDA 510(k) record. The listed applicant is Otodynamics. It received FDA 510(k) clearance on 2024-06-21 under 510(k) number K234095. 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 OtoNova/OtoNova Pro?

OtoNova/OtoNova Pro is a medical device that received FDA 510(k) clearance on 2024-06-21. The listed applicant is Otodynamics. The 510(k) number is K234095.

When did OtoNova/OtoNova Pro receive FDA 510(k) clearance?

OtoNova/OtoNova Pro received FDA 510(k) clearance on 2024-06-21, under 510(k) number K234095.

Who is the listed applicant for OtoNova/OtoNova Pro?

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

What is the FDA product code for OtoNova/OtoNova Pro?

The FDA product code for OtoNova/OtoNova Pro is EWO.

Other records listing Otodynamics 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.

K240430Otoport Pro

Related Devices (Code: EWO)

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Official Source

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