FDA 510(k)

DeVilbiss 5 升制氧机（555）

K号: K253549 · 2026-03-26

决定日期2026-03-26

产品代码CAW

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决定实质等同

器械摘要

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.

常见问题

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.

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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官方来源

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