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FDA 510(k)

腸內給養擴充套組

K 號:K203633 · 2021-08-19

決定日期2021-08-19
產品代碼PIF
諮詢委員會GU
決定相當於

器材摘要

Enteral Extension Sets is the device name listed in this FDA 510(k) record. The listed applicant is GBUK Group, Ltd.. It received FDA 510(k) clearance on 2021-08-19 under 510(k) number K203633. The device is classified under product code PIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Enteral Extension Sets?

Enteral Extension Sets is a medical device that received FDA 510(k) clearance on 2021-08-19. The listed applicant is GBUK Group, Ltd.. The 510(k) number is K203633.

When did Enteral Extension Sets receive FDA 510(k) clearance?

Enteral Extension Sets received FDA 510(k) clearance on 2021-08-19, under 510(k) number K203633.

Who is the listed applicant for Enteral Extension Sets?

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

What is the FDA product code for Enteral Extension Sets?

The FDA product code for Enteral Extension Sets is PIF.

相關臨床試驗

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其他以 GBUK Group, Ltd. 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。

相關器械(代碼:PIF)

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。

官方來源

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