FDA 510(k)

Invacare Platinum 5NXG 氧气浓缩器

K号: K203210 · 2021-04-12

决定日期2021-04-12

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 Platinum 5NXG 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 2021-04-12 under 510(k) number K203210. 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 Platinum 5NXG Oxygen Concentrator?

Invacare Platinum 5NXG Oxygen Concentrator is a medical device that received FDA 510(k) clearance on 2021-04-12. The listed applicant is Invacare Corporation. The 510(k) number is K203210.

When did Invacare Platinum 5NXG Oxygen Concentrator receive FDA 510(k) clearance?

Invacare Platinum 5NXG Oxygen Concentrator received FDA 510(k) clearance on 2021-04-12, under 510(k) number K203210.

Who is the listed applicant for Invacare Platinum 5NXG 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 Platinum 5NXG Oxygen Concentrator?

The FDA product code for Invacare Platinum 5NXG Oxygen Concentrator is CAW.

列明Invacare Corporation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。

K202379Invacare AVIVA Storm RX 动力轮椅 K200890Invacare Perfecto2V 氧气浓缩器 K192216Invacare AVIVA FX 动力轮椅，型号：IFX-20MP K191159单电池组浓缩器，带肩带携带包，背包肩带，A，POC1 USB 蓝牙适配器，POC1 Invacare 移动医疗应用程序配件，用于 iOS 和 Android 设备，Invacare Platinum 移动制氧机带连接功能 K182946Invacare TDX SP2-HD 配有船长座椅 K181090Invacare® Solara® 3G 和 Solara® 3G Spree 手动轮椅

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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。