FDA 510(k)

HepaShield 细菌病毒呼吸系统过滤器

K号: K191909 · 2020-03-23

决定日期2020-03-23

产品代码CAH

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决定实质等同

器械摘要

HepaShield Bacterial Viral Breathing System Filter is the device name listed in this FDA 510(k) record. The listed applicant is Flexicare Medical Limited.. It received FDA 510(k) clearance on 2020-03-23 under 510(k) number K191909. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the HepaShield Bacterial Viral Breathing System Filter?

HepaShield Bacterial Viral Breathing System Filter is a medical device that received FDA 510(k) clearance on 2020-03-23. The listed applicant is Flexicare Medical Limited.. The 510(k) number is K191909.

When did HepaShield Bacterial Viral Breathing System Filter receive FDA 510(k) clearance?

HepaShield Bacterial Viral Breathing System Filter received FDA 510(k) clearance on 2020-03-23, under 510(k) number K191909.

Who is the listed applicant for HepaShield Bacterial Viral Breathing System Filter?

FDA 510(k)记录中列出Flexicare Medical Limited.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 HepaShield Bacterial Viral Breathing System Filter?

The FDA product code for HepaShield Bacterial Viral Breathing System Filter is CAH.

列明Flexicare Medical Limited.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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