FDA 510(k)

DeVilbiss 5公升氧濃度濃縮機（555）

K 號：K253549 · 2026-03-26

決定日期2026-03-26

產品代碼CAW

諮詢委員會AN

決定相當於

器材摘要

DeVilbiss 5 Liter Oxygen Concentrator (555) 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 2026-03-26 under 510(k) number K253549. 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 DeVilbiss 5 Liter Oxygen Concentrator (555)?

DeVilbiss 5 Liter Oxygen Concentrator (555) is a medical device that received FDA 510(k) clearance on 2026-03-26. The listed applicant is Devilbiss Healthcare, LLC. The 510(k) number is K253549.

When did DeVilbiss 5 Liter Oxygen Concentrator (555) receive FDA 510(k) clearance?

DeVilbiss 5 Liter Oxygen Concentrator (555) received FDA 510(k) clearance on 2026-03-26, under 510(k) number K253549.

Who is the listed applicant for DeVilbiss 5 Liter Oxygen Concentrator (555)?

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 DeVilbiss 5 Liter Oxygen Concentrator (555)?

The FDA product code for DeVilbiss 5 Liter Oxygen Concentrator (555) 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。

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官方來源

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