FDA 510(k)

氧濃度濃縮器（型號：KSW-5、KSN-5、KSOC-5）

K 號：K223740 · 2023-10-05

申請人Jiangsu Konsung Bio-Medical Science and Technology Co., Ltd.

決定日期2023-10-05

產品代碼CAW

諮詢委員會AN

決定相當於

器材摘要

Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5) is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Konsung Bio-Medical Science and Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-10-05 under 510(k) number K223740. 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: KSW-5, KSN-5, KSOC-5)?

Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5) is a medical device that received FDA 510(k) clearance on 2023-10-05. The listed applicant is Jiangsu Konsung Bio-Medical Science and Technology Co., Ltd.. The 510(k) number is K223740.

When did Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5) receive FDA 510(k) clearance?

Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5) received FDA 510(k) clearance on 2023-10-05, under 510(k) number K223740.

Who is the listed applicant for Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5)?

The FDA 510(k) record lists Jiangsu Konsung Bio-Medical Science and Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5)?

The FDA product code for Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5) is CAW.

其他以 Jiangsu Konsung Bio-Medical Science and Technology 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。

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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。

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官方來源

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