FDA 510(k)

守護針電極

K 號：K200984 · 2020-05-27

決定日期2020-05-27

產品代碼GXZ

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

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.

常見問題

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.

其他以 Rhythmlink International, LLC 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：GXZ）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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