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FDA 510(k)

定量心电图检测器（QED 2000）

K号: K152135 · 2016-08-09

申请人Acme Portable Machines, Inc.
决定日期2016-08-09
产品代码DPS
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

Quantitative Electrocardiographic Detector (QED 2000) is the device name listed in this FDA 510(k) record. The listed applicant is Acme Portable Machines, Inc.. It received FDA 510(k) clearance on 2016-08-09 under 510(k) number K152135. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Quantitative Electrocardiographic Detector (QED 2000)?

Quantitative Electrocardiographic Detector (QED 2000) is a medical device that received FDA 510(k) clearance on 2016-08-09. The listed applicant is Acme Portable Machines, Inc.. The 510(k) number is K152135.

When did Quantitative Electrocardiographic Detector (QED 2000) receive FDA 510(k) clearance?

Quantitative Electrocardiographic Detector (QED 2000) received FDA 510(k) clearance on 2016-08-09, under 510(k) number K152135.

Who is the listed applicant for Quantitative Electrocardiographic Detector (QED 2000)?

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

What is the FDA product code for Quantitative Electrocardiographic Detector (QED 2000)?

The FDA product code for Quantitative Electrocardiographic Detector (QED 2000) is DPS.

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：DPS）

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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