FDA 510(k)

DIXI 医疗微深电极

K号: K170959 · 2017-11-24

决定日期2017-11-24

产品代码GZL

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决定实质等同

器械摘要

DIXI Medical Microdeep Depth Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Dixi Medical. It received FDA 510(k) clearance on 2017-11-24 under 510(k) number K170959. 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 DIXI Medical Microdeep Depth Electrode?

DIXI Medical Microdeep Depth Electrode is a medical device that received FDA 510(k) clearance on 2017-11-24. The listed applicant is Dixi Medical. The 510(k) number is K170959.

When did DIXI Medical Microdeep Depth Electrode receive FDA 510(k) clearance?

DIXI Medical Microdeep Depth Electrode received FDA 510(k) clearance on 2017-11-24, under 510(k) number K170959.

Who is the listed applicant for DIXI Medical Microdeep Depth Electrode?

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

What is the FDA product code for DIXI Medical Microdeep Depth Electrode?

The FDA product code for DIXI Medical Microdeep Depth Electrode is GZL.

列明Dixi Medical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。

K202087DIXI 医疗微深微-宏观深度电极 K201931Dixi Medical 手术室下脑膜电极（条带和网格）

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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