FDA 510(k)

便携式制氧机（JM-P50A）

K号: K251130 · 2025-08-21

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

决定日期2025-08-21

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 (JM-P50A) 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 2025-08-21 under 510(k) number K251130. 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 (JM-P50A)?

Portable Oxygen Concentrator (JM-P50A) is a medical device that received FDA 510(k) clearance on 2025-08-21. The listed applicant is Jiangsu Jumao X-Care Medical Equipment Co., Ltd.. The 510(k) number is K251130.

When did Portable Oxygen Concentrator (JM-P50A) receive FDA 510(k) clearance?

Portable Oxygen Concentrator (JM-P50A) received FDA 510(k) clearance on 2025-08-21, under 510(k) number K251130.

Who is the listed applicant for Portable Oxygen Concentrator (JM-P50A)?

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 Portable Oxygen Concentrator (JM-P50A)?

The FDA product code for Portable Oxygen Concentrator (JM-P50A) 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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