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FDA 510(k)

麗芭3系統

K 號：K182532 · 2019-05-15

申請人National Cardiac, Inc.
決定日期2019-05-15
產品代碼DSI
諮詢委員會履歷
決定相當於

器材摘要

Liba3 System is the device name listed in this FDA 510(k) record. The listed applicant is National Cardiac, Inc.. It received FDA 510(k) clearance on 2019-05-15 under 510(k) number K182532. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Liba3 System?

Liba3 System is a medical device that received FDA 510(k) clearance on 2019-05-15. The listed applicant is National Cardiac, Inc.. The 510(k) number is K182532.

When did Liba3 System receive FDA 510(k) clearance?

Liba3 System received FDA 510(k) clearance on 2019-05-15, under 510(k) number K182532.

Who is the listed applicant for Liba3 System?

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

What is the FDA product code for Liba3 System?

The FDA product code for Liba3 System is DSI.

相關臨床試驗

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相關器械（代碼：DSI）

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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