FDA 510(k)

SherpaPak 肺臟保存系統，SherpaPak 肝臟運輸系統

K 號：K192869 · 2020-01-16

決定日期2020-01-16

產品代碼KDN

諮詢委員會GU

決定Unknown

器材摘要

SherpaPak Lung Preservation System , SherpaPak Liver Transport System is the device name listed in this FDA 510(k) record. The listed applicant is Pragonix Technologies. It received FDA 510(k) clearance on 2020-01-16 under 510(k) number K192869. The device is classified under product code KDN. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

常見問題

What is the SherpaPak Lung Preservation System , SherpaPak Liver Transport System?

SherpaPak Lung Preservation System , SherpaPak Liver Transport System is a medical device that received FDA 510(k) clearance on 2020-01-16. The listed applicant is Pragonix Technologies. The 510(k) number is K192869.

When did SherpaPak Lung Preservation System , SherpaPak Liver Transport System receive FDA 510(k) clearance?

SherpaPak Lung Preservation System , SherpaPak Liver Transport System received FDA 510(k) clearance on 2020-01-16, under 510(k) number K192869.

Who is the listed applicant for SherpaPak Lung Preservation System , SherpaPak Liver Transport System?

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

What is the FDA product code for SherpaPak Lung Preservation System , SherpaPak Liver Transport System?

The FDA product code for SherpaPak Lung Preservation System , SherpaPak Liver Transport System is KDN.

相關器械（代碼：KDN）

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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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

器材摘要

常見問題

相關臨床試驗

相關器械（代碼：KDN）

官方來源