FDA 510(k)

Aspira 胸膜引流系統

K 號：K212696 · 2023-03-03

決定日期2023-03-03

產品代碼DWM

諮詢委員會履歷

決定相當於

器材摘要

Aspira Pleural Drainage System is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2023-03-03 under 510(k) number K212696. The device is classified under product code DWM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Aspira Pleural Drainage System?

Aspira Pleural Drainage System is a medical device that received FDA 510(k) clearance on 2023-03-03. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K212696.

When did Aspira Pleural Drainage System receive FDA 510(k) clearance?

Aspira Pleural Drainage System received FDA 510(k) clearance on 2023-03-03, under 510(k) number K212696.

Who is the listed applicant for Aspira Pleural Drainage System?

FDA 510(k) 記錄將 Merit Medical Systems, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Aspira Pleural Drainage System?

The FDA product code for Aspira Pleural Drainage System is DWM.

其他以 Merit Medical Systems, Inc. 為申請人之記錄

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相關器械（代碼：DWM）

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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