FDA 510(k)

TrachCuff 套管控制器

K号: K220854 · 2023-04-14

决定日期2023-04-14

产品代码BSK

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

TrachCuff Cuff Controller is the device name listed in this FDA 510(k) record. The listed applicant is Aw Technologies Aps. It received FDA 510(k) clearance on 2023-04-14 under 510(k) number K220854. The device is classified under product code BSK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TrachCuff Cuff Controller?

TrachCuff Cuff Controller is a medical device that received FDA 510(k) clearance on 2023-04-14. The listed applicant is Aw Technologies Aps. The 510(k) number is K220854.

When did TrachCuff Cuff Controller receive FDA 510(k) clearance?

TrachCuff Cuff Controller received FDA 510(k) clearance on 2023-04-14, under 510(k) number K220854.

Who is the listed applicant for TrachCuff Cuff Controller?

FDA 510(k)记录显示Aw Technologies Aps为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for TrachCuff Cuff Controller?

The FDA product code for TrachCuff Cuff Controller is BSK.

列明Aw Technologies Aps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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官方来源

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