FDA 510(k)

Allergan Botox 针电极

K号: K173815 · 2018-06-29

决定日期2018-06-29

产品代码IKT

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决定实质等同

器械摘要

Allergan Botox 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 2018-06-29 under 510(k) number K173815. 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 Allergan Botox Needle Electrode?

Allergan Botox Needle Electrode is a medical device that received FDA 510(k) clearance on 2018-06-29. The listed applicant is Natus Manufacturing Limited. The 510(k) number is K173815.

When did Allergan Botox Needle Electrode receive FDA 510(k) clearance?

Allergan Botox Needle Electrode received FDA 510(k) clearance on 2018-06-29, under 510(k) number K173815.

Who is the listed applicant for Allergan Botox 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 Allergan Botox Needle Electrode?

The FDA product code for Allergan Botox 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。

K242346Grass® MR条件/CT杯电极 K161430Myoject Luer Lock Needle Electrode

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。

K253581一次性同心针电极 0.30x25mm 红色 (TE/B50700-001)；一次性同心针电极 0.40x25mm 黄色 (TE/B50700-002)；一次性同心针电极 0.30x30mm 粉色 (TE/B50700-006)；一次性同心针电极 0.45x37mm 绿色 (TE/B50700-003)；一次性同心针电极 0.45x50mm 蓝色 (TE/B50700-004)；一次性同心针电极 0.60x75mm 紫色 (TE/B50700-005)Technomed Europe K161430Myoject Luer Lock Needle ElectrodeNatus Manufacturing Limited K152984一次性同心针电极，一次性单极针电极，一次性EP针电极，一次性皮下注射针电极Bio Protech, Inc.

官方来源

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