FDA 510(k)

THD ANOPRESS

K号: K161785 · 2017-03-14

决定日期2017-03-14

产品代码KLA

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决定实质等同

器械摘要

THD ANOPRESS is the device name listed in this FDA 510(k) record. The listed applicant is Thd Spa. It received FDA 510(k) clearance on 2017-03-14 under 510(k) number K161785. The device is classified under product code KLA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the THD ANOPRESS?

THD ANOPRESS is a medical device that received FDA 510(k) clearance on 2017-03-14. The listed applicant is Thd Spa. The 510(k) number is K161785.

When did THD ANOPRESS receive FDA 510(k) clearance?

THD ANOPRESS received FDA 510(k) clearance on 2017-03-14, under 510(k) number K161785.

Who is the listed applicant for THD ANOPRESS?

The FDA 510(k) record lists Thd Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THD ANOPRESS?

The FDA product code for THD ANOPRESS is KLA.

列明Thd Spa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。

K211623THD Procto 软件系统 K193512THD Procto 软件系统 K180135THD Anopress with THD SensyProbe

官方来源

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