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FDA 510(k)

NX01 (NX01)

K-Number: K251550 · 2025-11-25

ApplicantNaox Technologies Sas
Decision Date2025-11-25
Product CodeOMC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NX01 (NX01) is a medical device manufactured by Naox Technologies Sas. It received FDA 510(k) clearance on 2025-11-25 under approval number K251550. The device is classified under product code OMC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NX01 (NX01)?

NX01 (NX01) is a medical device that received FDA 510(k) clearance on 2025-11-25. It is manufactured by Naox Technologies Sas. The 510(k) number is K251550.

When was NX01 (NX01) approved by the FDA?

NX01 (NX01) received FDA 510(k) clearance on 2025-11-25, under approval number K251550.

What company makes NX01 (NX01)?

NX01 (NX01) is manufactured by Naox Technologies Sas.

What is the FDA product code for NX01 (NX01)?

The FDA product code for NX01 (NX01) is OMC.

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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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