EP-TRACER 系统
K号: K161245 · 2016-08-05
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决定日期2016-08-05
产品代码DQK
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
EP-TRACER System is the device name listed in this FDA 510(k) record. The listed applicant is Cardio Tek, BV. It received FDA 510(k) clearance on 2016-08-05 under 510(k) number K161245. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the EP-TRACER System?
EP-TRACER System is a medical device that received FDA 510(k) clearance on 2016-08-05. The listed applicant is Cardio Tek, BV. The 510(k) number is K161245.
When did EP-TRACER System receive FDA 510(k) clearance?
EP-TRACER System received FDA 510(k) clearance on 2016-08-05, under 510(k) number K161245.
Who is the listed applicant for EP-TRACER System?
The FDA 510(k) record lists Cardio Tek, BV as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EP-TRACER System?
The FDA product code for EP-TRACER System is DQK.
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。
相关器械（代码：DQK）
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。
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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