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FDA 510(k)

Oxygen Concentrator, Model JAY-5AW

K-Number: K213210 · 2022-12-08

ApplicantLongfian Scitech Co., Ltd.
Decision Date2022-12-08
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Oxygen Concentrator, Model JAY-5AW is a medical device manufactured by Longfian Scitech Co., Ltd.. It received FDA 510(k) clearance on 2022-12-08 under approval number K213210. 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 JAY-5AW?

Oxygen Concentrator, Model JAY-5AW is a medical device that received FDA 510(k) clearance on 2022-12-08. It is manufactured by Longfian Scitech Co., Ltd.. The 510(k) number is K213210.

When was Oxygen Concentrator, Model JAY-5AW approved by the FDA?

Oxygen Concentrator, Model JAY-5AW received FDA 510(k) clearance on 2022-12-08, under approval number K213210.

What company makes Oxygen Concentrator, Model JAY-5AW?

Oxygen Concentrator, Model JAY-5AW is manufactured by Longfian Scitech Co., Ltd..

What is the FDA product code for Oxygen Concentrator, Model JAY-5AW?

The FDA product code for Oxygen Concentrator, Model JAY-5AW 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 Longfian Scitech Co., Ltd.

K243833Portable oxygen concentrator (JAY-1000P)

Related Devices (Code: CAW)

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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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