FDA 510(k)

ProFuse CAD

K 號：K173744 · 2018-11-21

申請人Eigen

決定日期2018-11-21

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

ProFuse CAD is the device name listed in this FDA 510(k) record. The listed applicant is Eigen. It received FDA 510(k) clearance on 2018-11-21 under 510(k) number K173744. 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 ProFuse CAD?

ProFuse CAD is a medical device that received FDA 510(k) clearance on 2018-11-21. The listed applicant is Eigen. The 510(k) number is K173744.

When did ProFuse CAD receive FDA 510(k) clearance?

ProFuse CAD received FDA 510(k) clearance on 2018-11-21, under 510(k) number K173744.

Who is the listed applicant for ProFuse CAD?

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

What is the FDA product code for ProFuse CAD?

The FDA product code for ProFuse CAD is LLZ.

其他以 Eigen 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：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。

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官方來源

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