FDA 510(k)

氧濃度濃縮機-P2-O5E

K 號：K251764 · 2025-12-22

申請人Qingdao Kingon Medical Science and Technology Co., Ltd.

決定日期2025-12-22

產品代碼CAW

諮詢委員會AN

決定相當於

器材摘要

Oxygen Concentrator-P2-O5E is the device name listed in this FDA 510(k) record. The listed applicant is Qingdao Kingon Medical Science and Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-12-22 under 510(k) number K251764. 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-P2-O5E?

Oxygen Concentrator-P2-O5E is a medical device that received FDA 510(k) clearance on 2025-12-22. The listed applicant is Qingdao Kingon Medical Science and Technology Co., Ltd.. The 510(k) number is K251764.

When did Oxygen Concentrator-P2-O5E receive FDA 510(k) clearance?

Oxygen Concentrator-P2-O5E received FDA 510(k) clearance on 2025-12-22, under 510(k) number K251764.

Who is the listed applicant for Oxygen Concentrator-P2-O5E?

The FDA 510(k) record lists Qingdao Kingon 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-P2-O5E?

The FDA product code for Oxygen Concentrator-P2-O5E is CAW.

其他以 Qingdao Kingon Medical Science and Technology Co., Ltd. 為申請人之記錄

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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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