FDA 510(k)

DUTAU-NOVATECH®

K-Number: K242324 · 2025-02-06

Decision Date2025-02-06

Product CodeEOQ

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

DUTAU-NOVATECH® is a medical device manufactured by Novatech SA. It received FDA 510(k) clearance on 2025-02-06 under approval number K242324. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUTAU-NOVATECH®?

DUTAU-NOVATECH® is a medical device that received FDA 510(k) clearance on 2025-02-06. It is manufactured by Novatech SA. The 510(k) number is K242324.

When was DUTAU-NOVATECH® approved by the FDA?

DUTAU-NOVATECH® received FDA 510(k) clearance on 2025-02-06, under approval number K242324.

What company makes DUTAU-NOVATECH®?

DUTAU-NOVATECH® is manufactured by Novatech SA.

What is the FDA product code for DUTAU-NOVATECH®?

The FDA product code for DUTAU-NOVATECH® is EOQ.

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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.