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FDA 510(k)

可重复使用和自粘电极

K号: K180773 · 2018-05-22

申请人Shaoxing Dongzhi Electrical Technology Co., Ltd.
决定日期2018-05-22
产品代码GXY
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

Reusable and Self-Adhesive Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Shaoxing Dongzhi Electrical Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-05-22 under 510(k) number K180773. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Reusable and Self-Adhesive Electrodes?

Reusable and Self-Adhesive Electrodes is a medical device that received FDA 510(k) clearance on 2018-05-22. The listed applicant is Shaoxing Dongzhi Electrical Technology Co., Ltd.. The 510(k) number is K180773.

When did Reusable and Self-Adhesive Electrodes receive FDA 510(k) clearance?

Reusable and Self-Adhesive Electrodes received FDA 510(k) clearance on 2018-05-22, under 510(k) number K180773.

Who is the listed applicant for Reusable and Self-Adhesive Electrodes?

The FDA 510(k) record lists Shaoxing Dongzhi Electrical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reusable and Self-Adhesive Electrodes?

The FDA product code for Reusable and Self-Adhesive Electrodes is GXY.

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相关器械（代码：GXY）

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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