FDA 510(k)

Neocis引导系统

K号: K182776 · 2018-12-21

决定日期2018-12-21

产品代码PLV

咨询委员会DE 请注意，您没有提供具体的医疗设备监管文本内容，因此我无法进行翻译。请提供需要翻译的具体文本，我将根据您的要求进行翻译。

决定实质等同

器械摘要

Neocis Guidance System is the device name listed in this FDA 510(k) record. The listed applicant is Neocis, Inc.. It received FDA 510(k) clearance on 2018-12-21 under 510(k) number K182776. The device is classified under product code PLV. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Neocis Guidance System?

Neocis Guidance System is a medical device that received FDA 510(k) clearance on 2018-12-21. The listed applicant is Neocis, Inc.. The 510(k) number is K182776.

When did Neocis Guidance System receive FDA 510(k) clearance?

Neocis Guidance System received FDA 510(k) clearance on 2018-12-21, under 510(k) number K182776.

Who is the listed applicant for Neocis Guidance System?

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

What is the FDA product code for Neocis Guidance System?

The FDA product code for Neocis Guidance System is PLV.

列明Neocis, Inc.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。

K252376Yomi S 机器人系统 K251835Yomi机器人系统 K231018Yomi机器人系统 K222750Yomi机器人系统 K222049Yomi机器人系统 K211466Yomi机器人系统及YomiPlan Go

查看所有 18 个设备 →

官方来源

在 FDA 数据库中查看 →

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。