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FDA 510(k)

Invacare Perfecto2V 氧气浓缩器

K号: K200890 · 2020-08-06

决定日期2020-08-06
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

Invacare Perfecto2V Oxygen Concentrator is the device name listed in this FDA 510(k) record. The listed applicant is Invacare Corporation. It received FDA 510(k) clearance on 2020-08-06 under 510(k) number K200890. 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 Invacare Perfecto2V Oxygen Concentrator?

Invacare Perfecto2V Oxygen Concentrator is a medical device that received FDA 510(k) clearance on 2020-08-06. The listed applicant is Invacare Corporation. The 510(k) number is K200890.

When did Invacare Perfecto2V Oxygen Concentrator receive FDA 510(k) clearance?

Invacare Perfecto2V Oxygen Concentrator received FDA 510(k) clearance on 2020-08-06, under 510(k) number K200890.

Who is the listed applicant for Invacare Perfecto2V Oxygen Concentrator?

The FDA 510(k) record lists Invacare Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Invacare Perfecto2V Oxygen Concentrator?

The FDA product code for Invacare Perfecto2V Oxygen Concentrator is CAW.

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列明Invacare Corporation为申报人的其他记录

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相关器械(代码:CAW)

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。

官方来源

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