FDA 510(k)

Neocis規劃軟體應用程式（NPSA）用於第三方電腦

K 號：K191363 · 2019-10-02

決定日期2019-10-02

產品代碼PLV

諮詢委員會DE

決定相當於

器材摘要

Neocis Planning Software Application (NPSA) for 3rd Party PCs is the device name listed in this FDA 510(k) record. The listed applicant is Neocis, Inc.. It received FDA 510(k) clearance on 2019-10-02 under 510(k) number K191363. 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 Planning Software Application (NPSA) for 3rd Party PCs?

Neocis Planning Software Application (NPSA) for 3rd Party PCs is a medical device that received FDA 510(k) clearance on 2019-10-02. The listed applicant is Neocis, Inc.. The 510(k) number is K191363.

When did Neocis Planning Software Application (NPSA) for 3rd Party PCs receive FDA 510(k) clearance?

Neocis Planning Software Application (NPSA) for 3rd Party PCs received FDA 510(k) clearance on 2019-10-02, under 510(k) number K191363.

Who is the listed applicant for Neocis Planning Software Application (NPSA) for 3rd Party PCs?

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 Planning Software Application (NPSA) for 3rd Party PCs?

The FDA product code for Neocis Planning Software Application (NPSA) for 3rd Party PCs 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。

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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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