FDA 510(k)

Ensite Velocity 心脏映射系统 v5.0, Ensite Automap 模块 v1.0

K号: K160187 · 2016-10-21

决定日期2016-10-21

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： --- 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

Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 is the device name listed in this FDA 510(k) record. The listed applicant is St Jude Medical. It received FDA 510(k) clearance on 2016-10-21 under 510(k) number K160187. 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 Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0?

Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 is a medical device that received FDA 510(k) clearance on 2016-10-21. The listed applicant is St Jude Medical. The 510(k) number is K160187.

When did Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 receive FDA 510(k) clearance?

Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 received FDA 510(k) clearance on 2016-10-21, under 510(k) number K160187.

Who is the listed applicant for Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0?

The FDA 510(k) record lists St Jude Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0?

The FDA product code for Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 is DQK.

列明St Jude Medical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。

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官方来源

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