FDA 510(k)

NeuroNav 系统，NeuroSmart 系统

K号: K172042 · 2018-02-27

决定日期2018-02-27

产品代码GZL

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决定实质等同

器械摘要

NeuroNav System, NeuroSmart System is the device name listed in this FDA 510(k) record. The listed applicant is Alpha Omega Engineering , Ltd.. It received FDA 510(k) clearance on 2018-02-27 under 510(k) number K172042. The device is classified under product code GZL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the NeuroNav System, NeuroSmart System?

NeuroNav System, NeuroSmart System is a medical device that received FDA 510(k) clearance on 2018-02-27. The listed applicant is Alpha Omega Engineering , Ltd.. The 510(k) number is K172042.

When did NeuroNav System, NeuroSmart System receive FDA 510(k) clearance?

NeuroNav System, NeuroSmart System received FDA 510(k) clearance on 2018-02-27, under 510(k) number K172042.

Who is the listed applicant for NeuroNav System, NeuroSmart System?

The FDA 510(k) record lists Alpha Omega Engineering , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NeuroNav System, NeuroSmart System?

The FDA product code for NeuroNav System, NeuroSmart System is GZL.

列明Alpha Omega Engineering , Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K250601Neuro Omega 系统; NeuroSmart 系统 K220553Neuro Omega 系统, NeuroSmart 系统 K191739无菌LeadConfirm K171581Neuro Omega 系统

相关器械（代码：GZL）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

官方来源

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