FDA 510(k)

氧濃度濃縮器（OX-5A、OX-5C）

K 號：K252965 · 2026-05-29

決定日期2026-05-29

產品代碼CAW

諮詢委員會AN

決定相當於

器材摘要

Oxygen Concentrator (OX-5A, OX-5C) is the device name listed in this FDA 510(k) record. The listed applicant is Oxytek Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-05-29 under 510(k) number K252965. 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 (OX-5A, OX-5C)?

Oxygen Concentrator (OX-5A, OX-5C) is a medical device that received FDA 510(k) clearance on 2026-05-29. The listed applicant is Oxytek Medical Technology Co., Ltd.. The 510(k) number is K252965.

When did Oxygen Concentrator (OX-5A, OX-5C) receive FDA 510(k) clearance?

Oxygen Concentrator (OX-5A, OX-5C) received FDA 510(k) clearance on 2026-05-29, under 510(k) number K252965.

Who is the listed applicant for Oxygen Concentrator (OX-5A, OX-5C)?

FDA 510(k) 記錄將氧鐵克醫療技術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 (OX-5A, OX-5C)?

The FDA product code for Oxygen Concentrator (OX-5A, OX-5C) is CAW.

其他以 Oxytek Medical 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。

K254289攜帶式氧氣濃縮器（OX-1A-E，OX-1B）

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.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 K251534氧濃度濃縮器（J10A）Foshan Kycare Medical Equipment Co., Ltd.

官方來源

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