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FDA 510(k)

Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5)

K-Number: K223740 · 2023-10-05

ApplicantJiangsu Konsung Bio-Medical Science and Technology Co., Ltd.
Decision Date2023-10-05
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5) is a medical device manufactured by Jiangsu Konsung Bio-Medical Science and Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-10-05 under approval number K223740. 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: KSW-5, KSN-5, KSOC-5)?

Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5) is a medical device that received FDA 510(k) clearance on 2023-10-05. It is manufactured by Jiangsu Konsung Bio-Medical Science and Technology Co., Ltd.. The 510(k) number is K223740.

When was Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5) approved by the FDA?

Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5) received FDA 510(k) clearance on 2023-10-05, under approval number K223740.

What company makes Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5)?

Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5) is manufactured by Jiangsu Konsung Bio-Medical Science and Technology Co., Ltd..

What is the FDA product code for Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5)?

The FDA product code for Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5) 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

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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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