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FDA 510(k)

Oxygen Concentrator (ZY-10AB/115)

K-Number: K240840 · 2024-12-06

ApplicantFoshan Care Medical Technology Co., Ltd.
Decision Date2024-12-06
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Oxygen Concentrator (ZY-10AB/115) is a medical device manufactured by Foshan Care Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-12-06 under approval number K240840. 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 (ZY-10AB/115)?

Oxygen Concentrator (ZY-10AB/115) is a medical device that received FDA 510(k) clearance on 2024-12-06. It is manufactured by Foshan Care Medical Technology Co., Ltd.. The 510(k) number is K240840.

When was Oxygen Concentrator (ZY-10AB/115) approved by the FDA?

Oxygen Concentrator (ZY-10AB/115) received FDA 510(k) clearance on 2024-12-06, under approval number K240840.

What company makes Oxygen Concentrator (ZY-10AB/115)?

Oxygen Concentrator (ZY-10AB/115) is manufactured by Foshan Care Medical Technology Co., Ltd..

What is the FDA product code for Oxygen Concentrator (ZY-10AB/115)?

The FDA product code for Oxygen Concentrator (ZY-10AB/115) is 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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