FDA 510(k)

氧气浓缩器 (J5A)

K号: K251607 · 2025-11-21

申请人Foshan Kycare Medical Equipment Co., Ltd.

决定日期2025-11-21

产品代码CAW

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决定实质等同

器械摘要

Oxygen Concentrator (J5A) is the device name listed in this FDA 510(k) record. The listed applicant is Foshan Kycare Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2025-11-21 under 510(k) number K251607. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Oxygen Concentrator (J5A)?

Oxygen Concentrator (J5A) is a medical device that received FDA 510(k) clearance on 2025-11-21. The listed applicant is Foshan Kycare Medical Equipment Co., Ltd.. The 510(k) number is K251607.

When did Oxygen Concentrator (J5A) receive FDA 510(k) clearance?

Oxygen Concentrator (J5A) received FDA 510(k) clearance on 2025-11-21, under 510(k) number K251607.

Who is the listed applicant for Oxygen Concentrator (J5A)?

The FDA 510(k) record lists Foshan Kycare Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Oxygen Concentrator (J5A)?

The FDA product code for Oxygen Concentrator (J5A) is CAW.

列明Foshan Kycare Medical Equipment Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K251534氧气浓缩器 (J10A)

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