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FDA 510(k)

OtoNova/OtoNova Pro

K-Number: K234095 · 2024-06-21

ApplicantOtodynamics
Decision Date2024-06-21
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OtoNova/OtoNova Pro is a medical device manufactured by Otodynamics. It received FDA 510(k) clearance on 2024-06-21 under approval 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. It is manufactured by Otodynamics. The 510(k) number is K234095.

When was OtoNova/OtoNova Pro approved by the FDA?

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

What company makes OtoNova/OtoNova Pro?

OtoNova/OtoNova Pro is manufactured by Otodynamics.

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

The FDA product code for OtoNova/OtoNova 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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