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FDA 510(k)

Oxygen Concentrator-P2-O5E

K-Number: K251764 · 2025-12-22

ApplicantQingdao Kingon Medical Science and Technology Co., Ltd.
Decision Date2025-12-22
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Oxygen Concentrator-P2-O5E is a medical device manufactured by Qingdao Kingon Medical Science and Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-12-22 under approval number K251764. 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 Oxygen Concentrator-P2-O5E?

Oxygen Concentrator-P2-O5E is a medical device that received FDA 510(k) clearance on 2025-12-22. It is manufactured by Qingdao Kingon Medical Science and Technology Co., Ltd.. The 510(k) number is K251764.

When was Oxygen Concentrator-P2-O5E approved by the FDA?

Oxygen Concentrator-P2-O5E received FDA 510(k) clearance on 2025-12-22, under approval number K251764.

What company makes Oxygen Concentrator-P2-O5E?

Oxygen Concentrator-P2-O5E is manufactured by Qingdao Kingon Medical Science and Technology Co., Ltd..

What is the FDA product code for Oxygen Concentrator-P2-O5E?

The FDA product code for Oxygen Concentrator-P2-O5E is CAW.

Other Devices by Qingdao Kingon Medical Science and Technology Co., Ltd.

K210371Portable Oxygen Concentrator, model: P2-E6 K230702Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3) K223379Portable Oxygen Concentrator (Model: P2-E7, P2-E) K242718Portable Oxygen Concentrator (P2-TOC)

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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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