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FDA 510(k)

Meritrans ECO可重复使用压力传感器，Meritrans ECO穹顶

K号: K221782 · 2023-03-17

申请人Merit Medical Pte. , Ltd.
决定日期2023-03-17
产品代码DRS
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

Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Pte. , Ltd.. It received FDA 510(k) clearance on 2023-03-17 under 510(k) number K221782. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes?

Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes is a medical device that received FDA 510(k) clearance on 2023-03-17. The listed applicant is Merit Medical Pte. , Ltd.. The 510(k) number is K221782.

When did Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes receive FDA 510(k) clearance?

Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes received FDA 510(k) clearance on 2023-03-17, under 510(k) number K221782.

Who is the listed applicant for Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes?

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

What is the FDA product code for Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes?

The FDA product code for Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes is DRS.

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：DRS）

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。

K254074TruPressProcerus EnterprisesK242909FloTrac 传感器；FloTrac Jr 传感器；Acumen IQ 传感器；VolumeView 传感器Edwards Lifesciences, LLCK172458HemoDraw Plus 闭式血液采样系统与 LogiCal 转换器套件，HemoDraw Plus 闭式血液采样系统与 Transtar 转换器套件Smiths Medical Asd, Inc.K163172HemoDraw Plus 闭式血液采样系统与 LogiCal 转换器套件，HemoDraw Plus 闭式血液采样系统与 Transtar 转换器套件Smiths Medical Asd, Inc.K161408Compass 固定器和MAPCenturion Medical Products CorporationK152472一次性压力传感器Zhejiang Haisheng Medical Device Co., Ltd.

官方来源

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