Owgels 氧氣濃縮機
K 號：K191875 · 2020-07-20
廣告
器材摘要
Owgels Oxygen Concentrator is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Life Light Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-07-20 under 510(k) number K191875. 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 Owgels Oxygen Concentrator?
Owgels Oxygen Concentrator is a medical device that received FDA 510(k) clearance on 2020-07-20. The listed applicant is Guangzhou Life Light Electronic Technology Co., Ltd.. The 510(k) number is K191875.
When did Owgels Oxygen Concentrator receive FDA 510(k) clearance?
Owgels Oxygen Concentrator received FDA 510(k) clearance on 2020-07-20, under 510(k) number K191875.
Who is the listed applicant for Owgels Oxygen Concentrator?
The FDA 510(k) record lists Guangzhou Life Light Electronic Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Owgels Oxygen Concentrator?
The FDA product code for Owgels Oxygen Concentrator 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。
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, LLCK253549DeVilbiss 5公升氧濃度濃縮機（555）Devilbiss Healthcare, LLC
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。
廣告