FDA 510(k)

DeVilbiss PulmO2 10 升制氧机（1060AW）

K号: K250805 · 2025-12-09

决定日期2025-12-09

产品代码CAW

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决定实质等同

器械摘要

DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) 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 2025-12-09 under 510(k) number K250805. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)?

DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) is a medical device that received FDA 510(k) clearance on 2025-12-09. The listed applicant is Devilbiss Healthcare, LLC. The 510(k) number is K250805.

When did DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) receive FDA 510(k) clearance?

DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) received FDA 510(k) clearance on 2025-12-09, under 510(k) number K250805.

Who is the listed applicant for DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)?

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 PulmO2 10-Liter Oxygen Concentrator (1060AW)?

The FDA product code for DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) is CAW.

列明Devilbiss Healthcare, LLC为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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