FDA 510(k)

NX01 (NX01)

K-Number: K251550 · 2025-11-25

Decision Date2025-11-25

Product CodeOMC

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

NX01 (NX01) is the device name listed in this FDA 510(k) record. The listed applicant is Naox Technologies Sas. It received FDA 510(k) clearance on 2025-11-25 under 510(k) 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. The listed applicant is Naox Technologies Sas. The 510(k) number is K251550.

When did NX01 (NX01) receive FDA 510(k) clearance?

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

Who is the listed applicant for NX01 (NX01)?

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

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

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

Related Devices (Code: OMC)

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.

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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.