FDA 510(k)

CorVista 系統搭配 PH 增強模組

K 號：K233666 · 2024-04-05

決定日期2024-04-05

產品代碼SAT

諮詢委員會履歷

決定相當於

器材摘要

CorVista System with PH Add-On is the device name listed in this FDA 510(k) record. The listed applicant is Analytics For Life, Inc.. It received FDA 510(k) clearance on 2024-04-05 under 510(k) number K233666. The device is classified under product code SAT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CorVista System with PH Add-On?

CorVista System with PH Add-On is a medical device that received FDA 510(k) clearance on 2024-04-05. The listed applicant is Analytics For Life, Inc.. The 510(k) number is K233666.

When did CorVista System with PH Add-On receive FDA 510(k) clearance?

CorVista System with PH Add-On received FDA 510(k) clearance on 2024-04-05, under 510(k) number K233666.

Who is the listed applicant for CorVista System with PH Add-On?

FDA 510(k) 記錄將 Analytics For Life, 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 CorVista System with PH Add-On?

The FDA product code for CorVista System with PH Add-On is SAT.

其他以 Analytics For Life, 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。

K253576CorVista System® 內建 PCWP 附加功能

相關器械（代碼：SAT）

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。

K253699Tempus 心電圖-PHTempus AI, Inc.K252360ECG-AI 肺高血壓（PH）12導電路演算法（1020）Anumana, Inc.

官方來源

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