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FDA 510(k)

Stealth系统，Stealth传感器，Stealth智能电缆，StealthView软件

K号: K162503 · 2017-03-24

申请人Cardiac Insight, Inc.
决定日期2017-03-24
产品代码DSH
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

Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Insight, Inc.. It received FDA 510(k) clearance on 2017-03-24 under 510(k) number K162503. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software?

Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software is a medical device that received FDA 510(k) clearance on 2017-03-24. The listed applicant is Cardiac Insight, Inc.. The 510(k) number is K162503.

When did Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software receive FDA 510(k) clearance?

Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software received FDA 510(k) clearance on 2017-03-24, under 510(k) number K162503.

Who is the listed applicant for Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software?

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

What is the FDA product code for Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software?

The FDA product code for Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software is DSH.

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：DSH）

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。

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