FDA 510(k)

氧气浓缩器

K号: K230969 · 2023-11-09

申请人Jiangsu Jumao X-Care Medical Equipment Co., Ltd.

决定日期2023-11-09

产品代码CAW

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决定实质等同

器械摘要

Oxygen Concentrator is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Jumao X-Care Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2023-11-09 under 510(k) number K230969. 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?

Oxygen Concentrator is a medical device that received FDA 510(k) clearance on 2023-11-09. The listed applicant is Jiangsu Jumao X-Care Medical Equipment Co., Ltd.. The 510(k) number is K230969.

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

Oxygen Concentrator received FDA 510(k) clearance on 2023-11-09, under 510(k) number K230969.

Who is the listed applicant for Oxygen Concentrator?

The FDA 510(k) record lists Jiangsu Jumao X-Care 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?

The FDA product code for Oxygen Concentrator is CAW.

列明Jiangsu Jumao X-Care 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。

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