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FDA 510(k)

Nissha 医疗技术中性电极

K号: K203494 · 2021-02-23

申请人Nissha Medical Technologies, Ltd.
决定日期2021-02-23
产品代码GEI
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

Nissha Medical Technologies Neutral Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Nissha Medical Technologies, Ltd.. It received FDA 510(k) clearance on 2021-02-23 under 510(k) number K203494. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Nissha Medical Technologies Neutral Electrodes?

Nissha Medical Technologies Neutral Electrodes is a medical device that received FDA 510(k) clearance on 2021-02-23. The listed applicant is Nissha Medical Technologies, Ltd.. The 510(k) number is K203494.

When did Nissha Medical Technologies Neutral Electrodes receive FDA 510(k) clearance?

Nissha Medical Technologies Neutral Electrodes received FDA 510(k) clearance on 2021-02-23, under 510(k) number K203494.

Who is the listed applicant for Nissha Medical Technologies Neutral Electrodes?

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

What is the FDA product code for Nissha Medical Technologies Neutral Electrodes?

The FDA product code for Nissha Medical Technologies Neutral Electrodes is GEI.

相关临床试验

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：GEI）

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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