FDA 510(k)

BiWaze 咳嗽

K号: K191912 · 2020-03-27

决定日期2020-03-27

产品代码NHJ

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

BiWaze Cough is the device name listed in this FDA 510(k) record. The listed applicant is Abmrc, LLC. It received FDA 510(k) clearance on 2020-03-27 under 510(k) number K191912. The device is classified under product code NHJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BiWaze Cough?

BiWaze Cough is a medical device that received FDA 510(k) clearance on 2020-03-27. The listed applicant is Abmrc, LLC. The 510(k) number is K191912.

When did BiWaze Cough receive FDA 510(k) clearance?

BiWaze Cough received FDA 510(k) clearance on 2020-03-27, under 510(k) number K191912.

Who is the listed applicant for BiWaze Cough?

FDA 510(k)记录中列出Abmrc, LLC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 BiWaze Cough?

The FDA product code for BiWaze Cough is NHJ.

列明Abmrc, LLC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。

K260604BiWaze 清洁系统 K231728BiWaze 清洁系统 K213564BiWaze 清洁系统

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。