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FDA 510(k)

Oxygen Concentrator (J10A)

K-Number: K251534 · 2025-12-29

ApplicantFoshan Kycare Medical Equipment Co., Ltd.
Decision Date2025-12-29
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Oxygen Concentrator (J10A) is a medical device manufactured by Foshan Kycare Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2025-12-29 under approval number K251534. 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 (J10A)?

Oxygen Concentrator (J10A) is a medical device that received FDA 510(k) clearance on 2025-12-29. It is manufactured by Foshan Kycare Medical Equipment Co., Ltd.. The 510(k) number is K251534.

When was Oxygen Concentrator (J10A) approved by the FDA?

Oxygen Concentrator (J10A) received FDA 510(k) clearance on 2025-12-29, under approval number K251534.

What company makes Oxygen Concentrator (J10A)?

Oxygen Concentrator (J10A) is manufactured by Foshan Kycare Medical Equipment Co., Ltd..

What is the FDA product code for Oxygen Concentrator (J10A)?

The FDA product code for Oxygen Concentrator (J10A) is CAW.

Other Devices by Foshan Kycare Medical Equipment Co., Ltd.

K251607Oxygen Concentrator (J5A)

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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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