Oxygen Concentrator
K-Number: K230969 · 2023-11-09
Decision Date2023-11-09
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Oxygen Concentrator is a medical device manufactured by Jiangsu Jumao X-Care Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2023-11-09 under approval number K230969. 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 2023-11-09. It is manufactured by Jiangsu Jumao X-Care Medical Equipment Co., Ltd.. The 510(k) number is K230969.
When was Oxygen Concentrator approved by the FDA?
Oxygen Concentrator received FDA 510(k) clearance on 2023-11-09, under approval number K230969.
What company makes Oxygen Concentrator?
Oxygen Concentrator is manufactured by Jiangsu Jumao X-Care Medical Equipment Co., Ltd..
What is the FDA product code for Oxygen Concentrator?
The FDA product code for Oxygen Concentrator is CAW.
Other Devices by Jiangsu Jumao X-Care Medical Equipment Co., Ltd.
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.