FDA 510(k)

Neocis導向系統（NGS）搭配Yomi計劃v2.0.1

K 號：K210711 · 2021-12-22

決定日期2021-12-22

產品代碼PLV

諮詢委員會DE

決定相當於

器材摘要

Neocis Guidance System (NGS) with Yomi Plan v2.0.1 is the device name listed in this FDA 510(k) record. The listed applicant is Neocis, Inc.. It received FDA 510(k) clearance on 2021-12-22 under 510(k) number K210711. The device is classified under product code PLV. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Neocis Guidance System (NGS) with Yomi Plan v2.0.1?

Neocis Guidance System (NGS) with Yomi Plan v2.0.1 is a medical device that received FDA 510(k) clearance on 2021-12-22. The listed applicant is Neocis, Inc.. The 510(k) number is K210711.

When did Neocis Guidance System (NGS) with Yomi Plan v2.0.1 receive FDA 510(k) clearance?

Neocis Guidance System (NGS) with Yomi Plan v2.0.1 received FDA 510(k) clearance on 2021-12-22, under 510(k) number K210711.

Who is the listed applicant for Neocis Guidance System (NGS) with Yomi Plan v2.0.1?

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 (NGS) with Yomi Plan v2.0.1?

The FDA product code for Neocis Guidance System (NGS) with Yomi Plan v2.0.1 is PLV.

其他以 Neocis, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K252376Yomi S機械人系統 K251835Yomi機器人系統 K231018Yomi機器人系統 K222750Yomi機器人系統 K222049Yomi機器人系統 K211466Yomi機器人系統搭配YomiPlan Go

查看所有 18 項裝置 →

相關器械（代碼：PLV）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K252376Yomi S機械人系統Neocis, Inc.K251835Yomi機器人系統Neocis, Inc.K233563NavidentClaronav, Inc.K231018Yomi機器人系統Neocis, Inc.K210947NavidentClaronav, Inc.K211466Yomi機器人系統搭配YomiPlan GoNeocis, Inc.

官方來源

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