FDA 510(k)

Yomi S 机器人系统

K号: K252376 · 2025-10-28

决定日期2025-10-28

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

Yomi S Robotic 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 2025-10-28 under 510(k) number K252376. 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 Yomi S Robotic System?

Yomi S Robotic System is a medical device that received FDA 510(k) clearance on 2025-10-28. The listed applicant is Neocis, Inc.. The 510(k) number is K252376.

When did Yomi S Robotic System receive FDA 510(k) clearance?

Yomi S Robotic System received FDA 510(k) clearance on 2025-10-28, under 510(k) number K252376.

Who is the listed applicant for Yomi S Robotic 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 Yomi S Robotic System?

The FDA product code for Yomi S Robotic 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。

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 K210711Neocis引导系统（NGS）带Yomi Plan v2.0.1

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。