FDA 510(k)

TRINITY/3D 前列腺套件

K号: K170521 · 2017-05-30

申请人Koelis

决定日期2017-05-30

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

TRINITY/3D PROSTATE SUITE is the device name listed in this FDA 510(k) record. The listed applicant is Koelis. It received FDA 510(k) clearance on 2017-05-30 under 510(k) number K170521. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TRINITY/3D PROSTATE SUITE?

TRINITY/3D PROSTATE SUITE is a medical device that received FDA 510(k) clearance on 2017-05-30. The listed applicant is Koelis. The 510(k) number is K170521.

When did TRINITY/3D PROSTATE SUITE receive FDA 510(k) clearance?

TRINITY/3D PROSTATE SUITE received FDA 510(k) clearance on 2017-05-30, under 510(k) number K170521.

Who is the listed applicant for TRINITY/3D PROSTATE SUITE?

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

What is the FDA product code for TRINITY/3D PROSTATE SUITE?

The FDA product code for TRINITY/3D PROSTATE SUITE is IYN.

列明Koelis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。

K180970一次性引导器KDNG00 K171040可重复使用的引导范围（PERINE范围、NAIL范围、CON-LEAD范围和LIN-LEAD范围）和STEADY PRO范围 K160357TRINITY

相关器械（代码：IYN）

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。

官方来源

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