FDA 510(k)

Oxygen Concentrator

K-Number: K172234 · 2018-06-01

Decision Date2018-06-01

Product CodeCAW

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Oxygen Concentrator is a medical device manufactured by Sysmed (China) Co., Ltd.. It received FDA 510(k) clearance on 2018-06-01 under approval number K172234. 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?

Oxygen Concentrator is a medical device that received FDA 510(k) clearance on 2018-06-01. It is manufactured by Sysmed (China) Co., Ltd.. The 510(k) number is K172234.

When was Oxygen Concentrator approved by the FDA?

Oxygen Concentrator received FDA 510(k) clearance on 2018-06-01, under approval number K172234.

What company makes Oxygen Concentrator?

Oxygen Concentrator is manufactured by Sysmed (China) Co., Ltd..

What is the FDA product code for Oxygen Concentrator?

The FDA product code for Oxygen Concentrator is CAW.

Other Devices by Sysmed (China) Co., Ltd.

K192177SysMed S/T

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 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.