NX01 (NX01)
K号: K251550 · 2025-11-25
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决定日期2025-11-25
产品代码OMC
咨询委员会NE
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决定实质等同
器械摘要
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.
常见问题
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.
相关器械（代码：OMC）
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官方来源
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