FDA 510(k)

Guardian Needle Electrode

K号: K200984 · 2020-05-27

决定日期2020-05-27

产品代码GXZ

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决定实质等同

器械摘要

Guardian Needle Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Rhythmlink International, LLC. It received FDA 510(k) clearance on 2020-05-27 under 510(k) number K200984. The device is classified under product code GXZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Guardian Needle Electrode?

Guardian Needle Electrode is a medical device that received FDA 510(k) clearance on 2020-05-27. The listed applicant is Rhythmlink International, LLC. The 510(k) number is K200984.

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

Guardian Needle Electrode received FDA 510(k) clearance on 2020-05-27, under 510(k) number K200984.

Who is the listed applicant for Guardian Needle Electrode?

The FDA 510(k) record lists Rhythmlink International, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Guardian Needle Electrode?

The FDA product code for Guardian Needle Electrode is GXZ.

列明Rhythmlink International, LLC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。

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