FDA 510(k)

Assert-IQ® 插入式心臟監護器

K 號：K230286 · 2023-05-17

決定日期2023-05-17

產品代碼MXC

諮詢委員會履歷

決定相當於

器材摘要

Assert-IQ™ Insertable Cardiac Monitor is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2023-05-17 under 510(k) number K230286. The device is classified under product code MXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Assert-IQ™ Insertable Cardiac Monitor?

Assert-IQ™ Insertable Cardiac Monitor is a medical device that received FDA 510(k) clearance on 2023-05-17. The listed applicant is ABBOTT MEDICAL. The 510(k) number is K230286.

When did Assert-IQ™ Insertable Cardiac Monitor receive FDA 510(k) clearance?

Assert-IQ™ Insertable Cardiac Monitor received FDA 510(k) clearance on 2023-05-17, under 510(k) number K230286.

Who is the listed applicant for Assert-IQ™ Insertable Cardiac Monitor?

The FDA 510(k) record lists ABBOTT MEDICAL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Assert-IQ™ Insertable Cardiac Monitor?

The FDA product code for Assert-IQ™ Insertable Cardiac Monitor is MXC.

其他以 ABBOTT MEDICAL 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：MXC）

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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