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FDA 510(k)

Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM

K号: K172457 · 2018-06-28

申请人Deltex Medical Limited
决定日期2018-06-28
产品代码DPW
咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。
决定实质等同

器械摘要

Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM is the device name listed in this FDA 510(k) record. The listed applicant is Deltex Medical Limited. It received FDA 510(k) clearance on 2018-06-28 under 510(k) number K172457. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM?

Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM is a medical device that received FDA 510(k) clearance on 2018-06-28. The listed applicant is Deltex Medical Limited. The 510(k) number is K172457.

When did Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM receive FDA 510(k) clearance?

Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM received FDA 510(k) clearance on 2018-06-28, under 510(k) number K172457.

Who is the listed applicant for Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM?

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

What is the FDA product code for Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM?

The FDA product code for Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM is DPW.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：DPW）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K260700BlueDop Vascular ExpertBlueDop Medical, Ltd.K252810FloPatch FP120Flosonics MedicalK251904VascuChek 套件，VascuChek 收发器，VascuChek 临床探头，VascuChek 扬声器底座（VC-KIT-02，VC-TRX-02，VC-CP-01，VC-SD-01）；VascuChek 套件，VascuChek 收发器，VascuChek 外科探头，VascuChek 扬声器底座（VC-KIT-02，VC-TRX-02，VC-SP-01，VC-SD-01）Remington Medical, Inc.K251114FloPatch FP120Flosonics MedicalK243852Elfor-LElfi-Tech , Ltd.K241583VascuChek 套件，VascuChek 收发器，VascuChek 临床探头，VascuChek 充电器（VC-KIT-01，VC-TRX-01，VC-CP-01，VC-CH-01）；VascuChek 套件，VascuChek 收发器，VascuChek 外科探头，VascuChek 充电器（VC-KIT-01，VC-TRX-01，VC-SP-01，VC-CH-01）Remington Medical, Inc.

官方来源

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