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FDA 510(k)

Drive DeVilbiss iGo 2 Portable Oxygen Concentrator

K-Number: K172648 · 2018-03-23

ApplicantDevilbiss Healthcare, LLC
Decision Date2018-03-23
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Drive DeVilbiss iGo 2 Portable Oxygen Concentrator is a medical device manufactured by Devilbiss Healthcare, LLC. It received FDA 510(k) clearance on 2018-03-23 under approval number K172648. 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 Drive DeVilbiss iGo 2 Portable Oxygen Concentrator?

Drive DeVilbiss iGo 2 Portable Oxygen Concentrator is a medical device that received FDA 510(k) clearance on 2018-03-23. It is manufactured by Devilbiss Healthcare, LLC. The 510(k) number is K172648.

When was Drive DeVilbiss iGo 2 Portable Oxygen Concentrator approved by the FDA?

Drive DeVilbiss iGo 2 Portable Oxygen Concentrator received FDA 510(k) clearance on 2018-03-23, under approval number K172648.

What company makes Drive DeVilbiss iGo 2 Portable Oxygen Concentrator?

Drive DeVilbiss iGo 2 Portable Oxygen Concentrator is manufactured by Devilbiss Healthcare, LLC.

What is the FDA product code for Drive DeVilbiss iGo 2 Portable Oxygen Concentrator?

The FDA product code for Drive DeVilbiss iGo 2 Portable Oxygen Concentrator is CAW.

Related Clinical Trials

NCT06868979 Optical Imaging in X-linked Disorders. RECRUITING NCT07257016 HFTO Via Tracheal Intubation in Neurocritical Patients COMPLETED NCT07512687 Titrated Ambulatory Oxygen in Fibrotic ILD and COPD With Isolated Exertional Hypoxemia NOT_YET_RECRUITING

Other Devices by Devilbiss Healthcare, LLC

K152810DeVilbiss DV6WM Wireless Modem K250805DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) K253549DeVilbiss 5 Liter Oxygen Concentrator (555)

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. 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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