FDA 510(k)

Ambu VivaSight 2 DLT，Ambu VivaSight 2 适配器電纜

K 號：K203749 · 2021-05-03

決定日期2021-05-03

產品代碼CBI

諮詢委員會AN

決定相當於

器材摘要

Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable is the device name listed in this FDA 510(k) record. The listed applicant is Ambu A/S. It received FDA 510(k) clearance on 2021-05-03 under 510(k) number K203749. The device is classified under product code CBI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable?

Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable is a medical device that received FDA 510(k) clearance on 2021-05-03. The listed applicant is Ambu A/S. The 510(k) number is K203749.

When did Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable receive FDA 510(k) clearance?

Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable received FDA 510(k) clearance on 2021-05-03, under 510(k) number K203749.

Who is the listed applicant for Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable?

FDA 510(k) 記錄將 Ambu A/S 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable?

The FDA product code for Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable is CBI.

其他以 Ambu A/S 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：CBI）

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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