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FDA 510(k)

Vios中央監控站監控軟體，Vios中央伺服器軟體

K 號：K173107 · 2018-07-26

申請人Vios Medical, Inc.
決定日期2018-07-26
產品代碼DXJ
諮詢委員會履歷
決定相當於

器材摘要

Vios Central Station Monitor Software, Vios Central Server Software is the device name listed in this FDA 510(k) record. The listed applicant is Vios Medical, Inc.. It received FDA 510(k) clearance on 2018-07-26 under 510(k) number K173107. The device is classified under product code DXJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Vios Central Station Monitor Software, Vios Central Server Software?

Vios Central Station Monitor Software, Vios Central Server Software is a medical device that received FDA 510(k) clearance on 2018-07-26. The listed applicant is Vios Medical, Inc.. The 510(k) number is K173107.

When did Vios Central Station Monitor Software, Vios Central Server Software receive FDA 510(k) clearance?

Vios Central Station Monitor Software, Vios Central Server Software received FDA 510(k) clearance on 2018-07-26, under 510(k) number K173107.

Who is the listed applicant for Vios Central Station Monitor Software, Vios Central Server Software?

The FDA 510(k) record lists Vios Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vios Central Station Monitor Software, Vios Central Server Software?

The FDA product code for Vios Central Station Monitor Software, Vios Central Server Software is DXJ.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Vios Medical, 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。

K172586Vios監控系統™ 型號 2050

相關器械（代碼：DXJ）

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。

K212003ESSENZ 患者監護儀Livanova Deutschland, GmbHK212208飛利浦 IntelliVue 監護軟體（修訂版 E.0X）Philips Medizin Systeme Boeblingen GmbHK201162Essence 55SP 大螢幕系統Shenyang Torch-Bigtide Digital Technology Co., Ltd.K180534飛利浦 IntelliVue 監護軟體Philips Medizin Systeme Boeblingen GmbHK173381Nexxis ORBarco N.V.K172969Essence 55S 大螢幕系統Shenyang Torch-Bigtide Digital Technology Co., Ltd.

官方來源

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