FDA 510(k)

Alexis 含有式抽提系統

K 號：K211043 · 2022-03-31

申請人Applied Medical Resources Corporation

決定日期2022-03-31

產品代碼GCJ

諮詢委員會GU

決定相當於

器材摘要

Alexis Contained Extraction System is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources Corporation. It received FDA 510(k) clearance on 2022-03-31 under 510(k) number K211043. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Alexis Contained Extraction System?

Alexis Contained Extraction System is a medical device that received FDA 510(k) clearance on 2022-03-31. The listed applicant is Applied Medical Resources Corporation. The 510(k) number is K211043.

When did Alexis Contained Extraction System receive FDA 510(k) clearance?

Alexis Contained Extraction System received FDA 510(k) clearance on 2022-03-31, under 510(k) number K211043.

Who is the listed applicant for Alexis Contained Extraction System?

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

What is the FDA product code for Alexis Contained Extraction System?

The FDA product code for Alexis Contained Extraction System is GCJ.

其他以 Applied Medical Resources Corporation 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：GCJ）

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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