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FDA 510(k)

GENIOVA aligners

K-Number: K233152 · 2024-12-12

Decision Date2024-12-12
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GENIOVA aligners is a medical device manufactured by Geniova Technologies Sociedad Limitada. It received FDA 510(k) clearance on 2024-12-12 under approval number K233152. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENIOVA aligners?

GENIOVA aligners is a medical device that received FDA 510(k) clearance on 2024-12-12. It is manufactured by Geniova Technologies Sociedad Limitada. The 510(k) number is K233152.

When was GENIOVA aligners approved by the FDA?

GENIOVA aligners received FDA 510(k) clearance on 2024-12-12, under approval number K233152.

What company makes GENIOVA aligners?

GENIOVA aligners is manufactured by Geniova Technologies Sociedad Limitada.

What is the FDA product code for GENIOVA aligners?

The FDA product code for GENIOVA aligners is NXC.

Related Devices (Code: NXC)

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.