Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A

K-Number: K213825 · 2023-04-28

ApplicantJiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Decision Date2023-04-28
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A is a medical device manufactured by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. It received FDA 510(k) clearance on 2023-04-28 under approval number K213825. 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 model 8F-3A, Oxygen Concentrator model 8F-5A?

Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A is a medical device that received FDA 510(k) clearance on 2023-04-28. It is manufactured by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. The 510(k) number is K213825.

When was Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A approved by the FDA?

Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A received FDA 510(k) clearance on 2023-04-28, under approval number K213825.

What company makes Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A?

Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A is manufactured by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd..

What is the FDA product code for Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A?

The FDA product code for Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A is CAW.

Related Clinical Trials

NCT05984563 Optimization Strategy for Oxygen Delivery Under Cardiopulmonary Bypass TERMINATED NCT06969560 WeRoaM: Wearable Remote Monitoring in Heart Failure RECRUITING NCT05343988 Percutaneous Neurostimulation to Treat Paroxysmal Sympathetic Hyperactivity in Children TERMINATED

Other Devices by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

K170605Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D K201864YUWELL Infrared Thermometer K200939Electronic Blood Pressure Monitor K203583YUWELL infrared ear thermometer: YHT101, YHT200 K221372YUWELL Electronic Blood Pressure Monitor K212385YUWELL Finger Pulse Oximeter

View all 12 devices →

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.

↑