免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料,僅供一般參考,不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

氧濃度濃縮機型號 8F-3A,氧濃度濃縮機型號 8F-5A

K 號:K213825 · 2023-04-28

決定日期2023-04-28
產品代碼CAW
諮詢委員會AN
決定相當於

器材摘要

Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. It received FDA 510(k) clearance on 2023-04-28 under 510(k) number K213825. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A?

Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A is a medical device that received FDA 510(k) clearance on 2023-04-28. The listed applicant is Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. The 510(k) number is K213825.

When did Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A receive FDA 510(k) clearance?

Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A received FDA 510(k) clearance on 2023-04-28, under 510(k) number K213825.

Who is the listed applicant for Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A?

FDA 510(k) 記錄將江蘇玉宇醫療設備與供應有限公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A?

The FDA product code for Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A is CAW.

相關臨床試驗

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。

其他以 Jiangsu Yuyue Medical Equipment & Supply Co., 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。

查看所有 13 項裝置 →

相關器械(代碼:CAW)

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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊,請始終參閱官方記錄。

↑