FDA 510(k)

Eclipse 2L

K 號：K183045 · 2019-04-30

決定日期2019-04-30

產品代碼MJN

諮詢委員會履歷

決定相當於

器材摘要

Eclipse 2L is the device name listed in this FDA 510(k) record. The listed applicant is Balt USA, LLC. It received FDA 510(k) clearance on 2019-04-30 under 510(k) number K183045. The device is classified under product code MJN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Eclipse 2L?

Eclipse 2L is a medical device that received FDA 510(k) clearance on 2019-04-30. The listed applicant is Balt USA, LLC. The 510(k) number is K183045.

When did Eclipse 2L receive FDA 510(k) clearance?

Eclipse 2L received FDA 510(k) clearance on 2019-04-30, under 510(k) number K183045.

Who is the listed applicant for Eclipse 2L?

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

What is the FDA product code for Eclipse 2L?

The FDA product code for Eclipse 2L is MJN.

其他以 Balt USA, LLC 為申請人之記錄

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相關器械（代碼：MJN）

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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