FDA 510(k)

DIXI 医疗微深微-宏观深度电极

K号: K202087 · 2021-11-18

决定日期2021-11-18

产品代码GZL

咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

DIXI Medical Microdeep Micro-Macro Depth Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Dixi Medical. It received FDA 510(k) clearance on 2021-11-18 under 510(k) number K202087. 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 Micro-Macro Depth Electrodes?

DIXI Medical Microdeep Micro-Macro Depth Electrodes is a medical device that received FDA 510(k) clearance on 2021-11-18. The listed applicant is Dixi Medical. The 510(k) number is K202087.

When did DIXI Medical Microdeep Micro-Macro Depth Electrodes receive FDA 510(k) clearance?

DIXI Medical Microdeep Micro-Macro Depth Electrodes received FDA 510(k) clearance on 2021-11-18, under 510(k) number K202087.

Who is the listed applicant for DIXI Medical Microdeep Micro-Macro Depth Electrodes?

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 Micro-Macro Depth Electrodes?

The FDA product code for DIXI Medical Microdeep Micro-Macro Depth Electrodes 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。

K201931Dixi Medical 手术室下脑膜电极（条带和网格）K170959DIXI 医疗微深电极

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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