FDA 510(k)

TrachCuff 頸帶控制器

K 號：K220854 · 2023-04-14

決定日期2023-04-14

產品代碼BSK

諮詢委員會AN

決定相當於

器材摘要

TrachCuff Cuff Controller is the device name listed in this FDA 510(k) record. The listed applicant is Aw Technologies Aps. It received FDA 510(k) clearance on 2023-04-14 under 510(k) number K220854. The device is classified under product code BSK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TrachCuff Cuff Controller?

TrachCuff Cuff Controller is a medical device that received FDA 510(k) clearance on 2023-04-14. The listed applicant is Aw Technologies Aps. The 510(k) number is K220854.

When did TrachCuff Cuff Controller receive FDA 510(k) clearance?

TrachCuff Cuff Controller received FDA 510(k) clearance on 2023-04-14, under 510(k) number K220854.

Who is the listed applicant for TrachCuff Cuff Controller?

FDA 510(k) 記錄將 Aw Technologies Aps 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for TrachCuff Cuff Controller?

The FDA product code for TrachCuff Cuff Controller is BSK.

其他以 Aw Technologies Aps 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。

K261499呼吸道清潔器

相關器械（代碼：BSK）

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。

K261499呼吸道清潔器Aw Technologies Aps K243562袖帶守護者Idmed K242642袖帶探索器Shanghai Longmann Tech Co., Ltd.K221477AG100sHospitech Respiration , Ltd.K202874普里坦貝頓腕壓力管理器Covidien, LLC K192611Cuffix 注意：此翻譯僅根據給定的政策進行，並保留公司/產品名稱、FDA、510(k)、PMA、NCT、PMID、識別符和網址。Biovo Technologies , Ltd.

官方來源

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