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FDA 510(k)

MFI-心臟

K 號:K173512 · 2018-02-05

決定日期2018-02-05
產品代碼LLZ
諮詢委員會RA
決定相當於

器材摘要

MFI-Cardiac is the device name listed in this FDA 510(k) record. The listed applicant is Multifunctional Imaging, LLC. It received FDA 510(k) clearance on 2018-02-05 under 510(k) number K173512. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MFI-Cardiac?

MFI-Cardiac is a medical device that received FDA 510(k) clearance on 2018-02-05. The listed applicant is Multifunctional Imaging, LLC. The 510(k) number is K173512.

When did MFI-Cardiac receive FDA 510(k) clearance?

MFI-Cardiac received FDA 510(k) clearance on 2018-02-05, under 510(k) number K173512.

Who is the listed applicant for MFI-Cardiac?

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

What is the FDA product code for MFI-Cardiac?

The FDA product code for MFI-Cardiac is LLZ.

相關臨床試驗

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相關器械(代碼:LLZ)

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。

官方來源

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