FDA 510(k)

攜帶式氧氣濃縮器（Spirit-3）

K 號：K242736 · 2025-06-05

申請人Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

決定日期2025-06-05

產品代碼CAW

諮詢委員會AN

決定相當於

器材摘要

Portable Oxygen Concentrator (Spirit-3) 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 2025-06-05 under 510(k) number K242736. 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 Portable Oxygen Concentrator (Spirit-3)?

Portable Oxygen Concentrator (Spirit-3) is a medical device that received FDA 510(k) clearance on 2025-06-05. The listed applicant is Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. The 510(k) number is K242736.

When did Portable Oxygen Concentrator (Spirit-3) receive FDA 510(k) clearance?

Portable Oxygen Concentrator (Spirit-3) received FDA 510(k) clearance on 2025-06-05, under 510(k) number K242736.

Who is the listed applicant for Portable Oxygen Concentrator (Spirit-3)?

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 Portable Oxygen Concentrator (Spirit-3)?

The FDA product code for Portable Oxygen Concentrator (Spirit-3) is CAW.

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。

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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。

K254289攜帶式氧氣濃縮器（OX-1A-E，OX-1B）Oxytek Medical Technology Co., Ltd.K260171攜帶式氧氣濃縮器（PO1 5B，PO1 6B）BMC Medical Co., Ltd.K252399可攜式氧氣濃縮器Honsun (Nantong) Co., Ltd.K252965氧濃度濃縮器（OX-5A、OX-5C）Oxytek Medical Technology Co., Ltd.K252407氧氣Go可攜式氧氣濃縮器（1400-7000）Mv Life, LLC K253549DeVilbiss 5公升氧濃度濃縮機（555）Devilbiss Healthcare, LLC

官方來源

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