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FDA 510(k)

DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)

K-Number: K250805 · 2025-12-09

ApplicantDevilbiss Healthcare, LLC
Decision Date2025-12-09
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) is a medical device manufactured by Devilbiss Healthcare, LLC. It received FDA 510(k) clearance on 2025-12-09 under approval number K250805. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Devilbiss Healthcare, LLC. The 510(k) number is K250805.

When was DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) approved by the FDA?

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

What company makes DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)?

DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) is manufactured by Devilbiss Healthcare, LLC.

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.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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