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FDA 510(k)

GCE Zen-O Portable Oxygen Concentrator

K-Number: K162433 · 2017-05-24

ApplicantOxus, Inc.
Decision Date2017-05-24
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

GCE Zen-O Portable Oxygen Concentrator is a medical device manufactured by Oxus, Inc.. It received FDA 510(k) clearance on 2017-05-24 under approval number K162433. 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 GCE Zen-O Portable Oxygen Concentrator?

GCE Zen-O Portable Oxygen Concentrator is a medical device that received FDA 510(k) clearance on 2017-05-24. It is manufactured by Oxus, Inc.. The 510(k) number is K162433.

When was GCE Zen-O Portable Oxygen Concentrator approved by the FDA?

GCE Zen-O Portable Oxygen Concentrator received FDA 510(k) clearance on 2017-05-24, under approval number K162433.

What company makes GCE Zen-O Portable Oxygen Concentrator?

GCE Zen-O Portable Oxygen Concentrator is manufactured by Oxus, Inc..

What is the FDA product code for GCE Zen-O Portable Oxygen Concentrator?

The FDA product code for GCE Zen-O Portable Oxygen Concentrator 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

Related PubMed Literature

PMID: 34857221 Comparative study of a novel portable indirect calorimeter to a reference breath-by-breath instrument and its use in telemedicine settings. Clinical nutrition ESPEN (2021)

Other Devices by Oxus, Inc.

K211056Oxus Sieve Beds

Related Devices (Code: CAW)

K160630Invacare Platinum Mobile Oxygen ConcentratorInvacare Corporation 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 K180837CONTEC Oxygen ConcentratorContec Medical System Co., Ltd.

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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