FDA 510(k)

Myoject Luer Lock Needle Electrode

K号: K161430 · 2017-03-02

决定日期2017-03-02

产品代码IKT

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决定实质等同

器械摘要

Myoject Luer Lock Needle Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Natus Manufacturing Limited. It received FDA 510(k) clearance on 2017-03-02 under 510(k) number K161430. The device is classified under product code IKT. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Myoject Luer Lock Needle Electrode?

Myoject Luer Lock Needle Electrode is a medical device that received FDA 510(k) clearance on 2017-03-02. The listed applicant is Natus Manufacturing Limited. The 510(k) number is K161430.

When did Myoject Luer Lock Needle Electrode receive FDA 510(k) clearance?

Myoject Luer Lock Needle Electrode received FDA 510(k) clearance on 2017-03-02, under 510(k) number K161430.

Who is the listed applicant for Myoject Luer Lock Needle Electrode?

The FDA 510(k) record lists Natus Manufacturing Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Myoject Luer Lock Needle Electrode?

The FDA product code for Myoject Luer Lock Needle Electrode is IKT.

列明Natus Manufacturing Limited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。

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相关器械（代码：IKT）

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。

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