低血压决策辅助
K号: K190955 · 2019-11-27
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决定日期2019-11-27
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
Hypotension Decision Assist is the device name listed in this FDA 510(k) record. The listed applicant is Directed Systems, Ltd.. It received FDA 510(k) clearance on 2019-11-27 under 510(k) number K190955. 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 Hypotension Decision Assist?
Hypotension Decision Assist is a medical device that received FDA 510(k) clearance on 2019-11-27. The listed applicant is Directed Systems, Ltd.. The 510(k) number is K190955.
When did Hypotension Decision Assist receive FDA 510(k) clearance?
Hypotension Decision Assist received FDA 510(k) clearance on 2019-11-27, under 510(k) number K190955.
Who is the listed applicant for Hypotension Decision Assist?
The FDA 510(k) record lists Directed Systems, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Hypotension Decision Assist?
The FDA product code for Hypotension Decision Assist 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Directed Systems, Ltd.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 SEK193179EV1000临床平台Edwards Lifesciences, LLC
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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