FDA 510(k)

便携式制氧机（Spirit-3）

K号: K242736 · 2025-06-05

申请人Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

决定日期2025-06-05

产品代码CAW

咨询委员会AN 请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。

决定实质等同

器械摘要

Portable Oxygen Concentrator (Spirit-3) is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. It received FDA 510(k) clearance on 2025-06-05 under 510(k) number K242736. 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 Portable Oxygen Concentrator (Spirit-3)?

Portable Oxygen Concentrator (Spirit-3) is a medical device that received FDA 510(k) clearance on 2025-06-05. The listed applicant is Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. The 510(k) number is K242736.

When did Portable Oxygen Concentrator (Spirit-3) receive FDA 510(k) clearance?

Portable Oxygen Concentrator (Spirit-3) received FDA 510(k) clearance on 2025-06-05, under 510(k) number K242736.

Who is the listed applicant for Portable Oxygen Concentrator (Spirit-3)?

FDA 510(k)记录将江苏宇悦医疗设备供应有限公司列为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Portable Oxygen Concentrator (Spirit-3)?

The FDA product code for Portable Oxygen Concentrator (Spirit-3) is CAW.

列明Jiangsu Yuyue Medical Equipment & Supply 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。

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