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FDA 510(k)

QMAPP 放大器; QMAPP 静力學監測系統; QMAPP PCM; QMAPP GO; QMAPP EP

K 號：K170032 · 2017-09-08

申請人Fysicon BV
決定日期2017-09-08
產品代碼MWI
諮詢委員會履歷
決定相當於

器材摘要

QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP is the device name listed in this FDA 510(k) record. The listed applicant is Fysicon BV. It received FDA 510(k) clearance on 2017-09-08 under 510(k) number K170032. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP?

QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP is a medical device that received FDA 510(k) clearance on 2017-09-08. The listed applicant is Fysicon BV. The 510(k) number is K170032.

When did QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP receive FDA 510(k) clearance?

QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP received FDA 510(k) clearance on 2017-09-08, under 510(k) number K170032.

Who is the listed applicant for QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP?

The FDA 510(k) record lists Fysicon BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP?

The FDA product code for QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP is MWI.

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 Fysicon BV 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。

K241766QMAPP® (Hemo、Hemo Lite、PCM、GO、Hybrid)

相關器械（代碼：MWI）

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。

K260438生命徵象監測器（CLEO2）Infinium Medical, Inc.K253417馬斯美Root監控系統Masimo CorporationK253196Midmark 800 電子生命徵象儀器（1-300-0100，1-300-0200，1-300-0300，1-300-0400）Midmark CorporationK253436c-med0 阿爾法Cosinuss GmbHK250135WAVE醫療平台（2.0.000）Baxter Healthcare Corp/ Excel MedicalK241766QMAPP® (Hemo、Hemo Lite、PCM、GO、Hybrid)Fysicon BV

官方來源

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