FDA 510(k)

Therapy Mask 3100 NC/SP

K号: K231313 · 2023-07-28

决定日期2023-07-28

产品代码BZD

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

Therapy Mask 3100 NC/SP is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 2023-07-28 under 510(k) number K231313. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Therapy Mask 3100 NC/SP?

Therapy Mask 3100 NC/SP is a medical device that received FDA 510(k) clearance on 2023-07-28. The listed applicant is Respironics, Inc.. The 510(k) number is K231313.

When did Therapy Mask 3100 NC/SP receive FDA 510(k) clearance?

Therapy Mask 3100 NC/SP received FDA 510(k) clearance on 2023-07-28, under 510(k) number K231313.

Who is the listed applicant for Therapy Mask 3100 NC/SP?

FDA 510(k)记录中列出Respironics, Inc.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 Therapy Mask 3100 NC/SP?

The FDA product code for Therapy Mask 3100 NC/SP is BZD.

列明Respironics, Inc.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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