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FDA 510(k)

Portable Oxygen Concentrator (Model: P2-E7, P2-E)

K-Number: K223379 · 2023-06-22

ApplicantQingdao Kingon Medical Science and Technology Co., Ltd.
Decision Date2023-06-22
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Portable Oxygen Concentrator (Model: P2-E7, P2-E) is a medical device manufactured by Qingdao Kingon Medical Science and Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-06-22 under approval number K223379. 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 (Model: P2-E7, P2-E)?

Portable Oxygen Concentrator (Model: P2-E7, P2-E) is a medical device that received FDA 510(k) clearance on 2023-06-22. It is manufactured by Qingdao Kingon Medical Science and Technology Co., Ltd.. The 510(k) number is K223379.

When was Portable Oxygen Concentrator (Model: P2-E7, P2-E) approved by the FDA?

Portable Oxygen Concentrator (Model: P2-E7, P2-E) received FDA 510(k) clearance on 2023-06-22, under approval number K223379.

What company makes Portable Oxygen Concentrator (Model: P2-E7, P2-E)?

Portable Oxygen Concentrator (Model: P2-E7, P2-E) is manufactured by Qingdao Kingon Medical Science and Technology Co., Ltd..

What is the FDA product code for Portable Oxygen Concentrator (Model: P2-E7, P2-E)?

The FDA product code for Portable Oxygen Concentrator (Model: P2-E7, P2-E) is CAW.

Related Clinical Trials

NCT05984563 Optimization Strategy for Oxygen Delivery Under Cardiopulmonary Bypass TERMINATED NCT06868979 Optical Imaging in X-linked Disorders. RECRUITING NCT06969560 WeRoaM: Wearable Remote Monitoring in Heart Failure RECRUITING NCT05343988 Percutaneous Neurostimulation to Treat Paroxysmal Sympathetic Hyperactivity in Children TERMINATED NCT07512687 Titrated Ambulatory Oxygen in Fibrotic ILD and COPD With Isolated Exertional Hypoxemia NOT_YET_RECRUITING

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) K251764Oxygen Concentrator-P2-O5E K242718Portable Oxygen Concentrator (P2-TOC)

Related Devices (Code: CAW)

K160630Invacare Platinum Mobile Oxygen ConcentratorInvacare Corporation K162433GCE Zen-O Portable Oxygen ConcentratorOxus, Inc. K182454O2 Concepts Oxlife Independence Model 301-0001O2 Concepts, LLC K172234Oxygen ConcentratorSysmed (China) Co., Ltd. K172648Drive DeVilbiss iGo 2 Portable Oxygen ConcentratorDevilbiss Healthcare, LLC K191159Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with ConnectivityInvacare Corporation

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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