FDA 510(k)

Niobe® 磁性導航系統 (MNS) 配備 Navigant 工作站 (NWS) 及 Cardiodri

K 號：K192775 · 2019-10-30

決定日期2019-10-30

產品代碼PJB

諮詢委員會履歷

決定相當於

器材摘要

Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri is the device name listed in this FDA 510(k) record. The listed applicant is Stereotaxis, Inc.. It received FDA 510(k) clearance on 2019-10-30 under 510(k) number K192775. The device is classified under product code PJB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri?

Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri is a medical device that received FDA 510(k) clearance on 2019-10-30. The listed applicant is Stereotaxis, Inc.. The 510(k) number is K192775.

When did Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri receive FDA 510(k) clearance?

Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri received FDA 510(k) clearance on 2019-10-30, under 510(k) number K192775.

Who is the listed applicant for Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri?

FDA 510(k) 記錄將Stereotaxis, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri?

The FDA product code for Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri is PJB.

其他以 Stereotaxis, 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。

K262744GenesisX RMN K253473同步 K251792Stereotaxis GenesisX RMN 配置 Navigant™工作站（NWS）K250590MAGiC Sweep™ EP描記電極导管 K193147Stereotaxis Genesis RMN 配置 Navigant 工作站 (NWS) 及 Cardiodrive 系統 K183027可調向心導管控制系統

查看所有 7 項裝置 →

相關器械（代碼：PJB）

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。

K193147Stereotaxis Genesis RMN 配置 Navigant 工作站 (NWS) 及 Cardiodrive 系統Stereotaxis, Inc.K183027可調向心導管控制系統Stereotaxis, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。