FDA 510(k)

Yomi机器人系统及YomiPlan Go

K号: K211466 · 2022-06-14

决定日期2022-06-14

产品代码PLV

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决定实质等同

器械摘要

Yomi Robotic System with YomiPlan Go is the device name listed in this FDA 510(k) record. The listed applicant is Neocis, Inc.. It received FDA 510(k) clearance on 2022-06-14 under 510(k) number K211466. 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 Robotic System with YomiPlan Go?

Yomi Robotic System with YomiPlan Go is a medical device that received FDA 510(k) clearance on 2022-06-14. The listed applicant is Neocis, Inc.. The 510(k) number is K211466.

When did Yomi Robotic System with YomiPlan Go receive FDA 510(k) clearance?

Yomi Robotic System with YomiPlan Go received FDA 510(k) clearance on 2022-06-14, under 510(k) number K211466.

Who is the listed applicant for Yomi Robotic System with YomiPlan Go?

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 Robotic System with YomiPlan Go?

The FDA product code for Yomi Robotic System with YomiPlan Go 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 K210711Neocis引导系统（NGS）带Yomi Plan v2.0.1

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官方来源

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