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FDA 510(k)

Portable Oxygen Concentrator (Spirit-3)

K-Number: K242736 · 2025-06-05

ApplicantJiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Decision Date2025-06-05
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Portable Oxygen Concentrator (Spirit-3) is a medical device manufactured by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. It received FDA 510(k) clearance on 2025-06-05 under approval number K242736. 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 Portable Oxygen Concentrator (Spirit-3)?

Portable Oxygen Concentrator (Spirit-3) is a medical device that received FDA 510(k) clearance on 2025-06-05. It is manufactured by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. The 510(k) number is K242736.

When was Portable Oxygen Concentrator (Spirit-3) approved by the FDA?

Portable Oxygen Concentrator (Spirit-3) received FDA 510(k) clearance on 2025-06-05, under approval number K242736.

What company makes Portable Oxygen Concentrator (Spirit-3)?

Portable Oxygen Concentrator (Spirit-3) is manufactured by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd..

What is the FDA product code for Portable Oxygen Concentrator (Spirit-3)?

The FDA product code for Portable Oxygen Concentrator (Spirit-3) is CAW.

Related Clinical Trials

NCT06868979 Optical Imaging in X-linked Disorders. RECRUITING NCT07512687 Titrated Ambulatory Oxygen in Fibrotic ILD and COPD With Isolated Exertional Hypoxemia NOT_YET_RECRUITING

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Related Devices (Code: 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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