FDA 510(k)

Scopis扩展器械套件EM

K号: K171661 · 2017-09-27

决定日期2017-09-27

产品代码PGW

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决定实质等同

器械摘要

Scopis Extended Instrument Set EM is the device name listed in this FDA 510(k) record. The listed applicant is Scopis GmbH. It received FDA 510(k) clearance on 2017-09-27 under 510(k) number K171661. The device is classified under product code PGW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Scopis Extended Instrument Set EM?

Scopis Extended Instrument Set EM is a medical device that received FDA 510(k) clearance on 2017-09-27. The listed applicant is Scopis GmbH. The 510(k) number is K171661.

When did Scopis Extended Instrument Set EM receive FDA 510(k) clearance?

Scopis Extended Instrument Set EM received FDA 510(k) clearance on 2017-09-27, under 510(k) number K171661.

Who is the listed applicant for Scopis Extended Instrument Set EM?

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

What is the FDA product code for Scopis Extended Instrument Set EM?

The FDA product code for Scopis Extended Instrument Set EM is PGW.

列明Scopis GmbH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。

K161491Scopis混合导航系统EM

相关器械（代码：PGW）

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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官方来源

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