FDA 510(k)

駕馭德維爾比斯 iGo 2 輕便氧氣濃縮器

K 號：K172648 · 2018-03-23

決定日期2018-03-23

產品代碼CAW

諮詢委員會AN

決定相當於

器材摘要

Drive DeVilbiss iGo 2 Portable Oxygen Concentrator is the device name listed in this FDA 510(k) record. The listed applicant is Devilbiss Healthcare, LLC. It received FDA 510(k) clearance on 2018-03-23 under 510(k) number K172648. 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 Drive DeVilbiss iGo 2 Portable Oxygen Concentrator?

Drive DeVilbiss iGo 2 Portable Oxygen Concentrator is a medical device that received FDA 510(k) clearance on 2018-03-23. The listed applicant is Devilbiss Healthcare, LLC. The 510(k) number is K172648.

When did Drive DeVilbiss iGo 2 Portable Oxygen Concentrator receive FDA 510(k) clearance?

Drive DeVilbiss iGo 2 Portable Oxygen Concentrator received FDA 510(k) clearance on 2018-03-23, under 510(k) number K172648.

Who is the listed applicant for Drive DeVilbiss iGo 2 Portable Oxygen Concentrator?

The FDA 510(k) record lists Devilbiss Healthcare, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Drive DeVilbiss iGo 2 Portable Oxygen Concentrator?

The FDA product code for Drive DeVilbiss iGo 2 Portable Oxygen Concentrator is CAW.

其他以 Devilbiss Healthcare, LLC 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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