FDA 510(k)

氧气浓缩器型号 8F-3A，氧气浓缩器型号 8F-5A

K号: K213825 · 2023-04-28

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

决定日期2023-04-28

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

Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A 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 2023-04-28 under 510(k) number K213825. 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 model 8F-3A, Oxygen Concentrator model 8F-5A?

Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A is a medical device that received FDA 510(k) clearance on 2023-04-28. The listed applicant is Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. The 510(k) number is K213825.

When did Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A receive FDA 510(k) clearance?

Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A received FDA 510(k) clearance on 2023-04-28, under 510(k) number K213825.

Who is the listed applicant for Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A?

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 Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A?

The FDA product code for Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A 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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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。