免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据，仅供一般参考，不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

CMS-2000 中央监护系统

K号: K172966 · 2017-12-08

申请人Advanced Instumentations, Inc.
决定日期2017-12-08
产品代码MHX
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

CMS-2000 Central Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Instumentations, Inc.. It received FDA 510(k) clearance on 2017-12-08 under 510(k) number K172966. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CMS-2000 Central Monitoring System?

CMS-2000 Central Monitoring System is a medical device that received FDA 510(k) clearance on 2017-12-08. The listed applicant is Advanced Instumentations, Inc.. The 510(k) number is K172966.

When did CMS-2000 Central Monitoring System receive FDA 510(k) clearance?

CMS-2000 Central Monitoring System received FDA 510(k) clearance on 2017-12-08, under 510(k) number K172966.

Who is the listed applicant for CMS-2000 Central Monitoring System?

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

What is the FDA product code for CMS-2000 Central Monitoring System?

The FDA product code for CMS-2000 Central Monitoring System is MHX.

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：MHX）

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。

K260656Carescape ONE；Carescape Dock F0；TruSignal ECG MM；TruSignal PRES MM；TruSignal TEMP MM；TruSignal SpO2 MM 1.8M；TruSignal SpO2 MM 3.0MGE Healthcare Finland OyK260343Carescape Canvas 1000；Carescape Canvas智能显示屏GE Healthcare Finland OyK260579Infinity® 急诊护理系统（IACS）- VG8.1Draeger Medical Systems, Inc.K251508遥测监测仪（iT30，iT50）Edan Instruments, Inc.K253277Monitor B105M；Monitor B125M；Monitor B155M；Monitor B105P；Monitor B125PGe Medical Systems Information Technologies, Inc.K254209Radius VSM和附件Masimo Corporation

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。

↑