EV1000临床平台
K号: K193179 · 2019-12-17
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决定日期2019-12-17
产品代码DXG
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：
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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
EV1000 Clinical Platform is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2019-12-17 under 510(k) number K193179. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the EV1000 Clinical Platform?
EV1000 Clinical Platform is a medical device that received FDA 510(k) clearance on 2019-12-17. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K193179.
When did EV1000 Clinical Platform receive FDA 510(k) clearance?
EV1000 Clinical Platform received FDA 510(k) clearance on 2019-12-17, under 510(k) number K193179.
Who is the listed applicant for EV1000 Clinical Platform?
The FDA 510(k) record lists Edwards Lifesciences, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EV1000 Clinical Platform?
The FDA product code for EV1000 Clinical Platform is DXG.
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。
列明Edwards Lifesciences, LLC为申报人的其他记录
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。
相关器械（代码：DXG）
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。
K253092Argos Infinity (Rev. 1.0)Retia Medical Systems, Inc.K251275VitalStream ART Connect；VitalStream-HemoCaretaker MedicalK232048Cogent™ 血流动力学监测系统; Cogent™ HMSIcu MedicalK212529低血压决策辅助模型HDA-OR2Directed Systems, Ltd.K192169PulsioFlex监控系统带ProAQT传感器Pulsion Medical Systems SEK190955低血压决策辅助Directed Systems, Ltd.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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