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FDA 510(k)

心座

K 號：K222330 · 2023-04-24

申請人Casana Care, Inc.
決定日期2023-04-24
產品代碼MWI
諮詢委員會履歷
決定相當於

器材摘要

The Heart Seat is the device name listed in this FDA 510(k) record. The listed applicant is Casana Care, Inc.. It received FDA 510(k) clearance on 2023-04-24 under 510(k) number K222330. 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 The Heart Seat?

The Heart Seat is a medical device that received FDA 510(k) clearance on 2023-04-24. The listed applicant is Casana Care, Inc.. The 510(k) number is K222330.

When did The Heart Seat receive FDA 510(k) clearance?

The Heart Seat received FDA 510(k) clearance on 2023-04-24, under 510(k) number K222330.

Who is the listed applicant for The Heart Seat?

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

What is the FDA product code for The Heart Seat?

The FDA product code for The Heart Seat 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

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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