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FDA 510(k)

Portable oxygen concentrator (JAY-1000P)

K-Number: K243833 · 2025-09-29

ApplicantLongfian Scitech Co., Ltd.
Decision Date2025-09-29
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Portable oxygen concentrator (JAY-1000P) is a medical device manufactured by Longfian Scitech Co., Ltd.. It received FDA 510(k) clearance on 2025-09-29 under approval number K243833. 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 (JAY-1000P)?

Portable oxygen concentrator (JAY-1000P) is a medical device that received FDA 510(k) clearance on 2025-09-29. It is manufactured by Longfian Scitech Co., Ltd.. The 510(k) number is K243833.

When was Portable oxygen concentrator (JAY-1000P) approved by the FDA?

Portable oxygen concentrator (JAY-1000P) received FDA 510(k) clearance on 2025-09-29, under approval number K243833.

What company makes Portable oxygen concentrator (JAY-1000P)?

Portable oxygen concentrator (JAY-1000P) is manufactured by Longfian Scitech Co., Ltd..

What is the FDA product code for Portable oxygen concentrator (JAY-1000P)?

The FDA product code for Portable oxygen concentrator (JAY-1000P) 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

Other Devices by Longfian Scitech Co., Ltd.

K213210Oxygen Concentrator, Model JAY-5AW

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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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