FDA 510(k)

SENTINEL 心脏病信息管理系统

K号: K152881 · 2016-04-01

决定日期2016-04-01

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

SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spacelabs Healthcare, Ltd.. It received FDA 510(k) clearance on 2016-04-01 under 510(k) number K152881. 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 SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM?

SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2016-04-01. The listed applicant is Spacelabs Healthcare, Ltd.. The 510(k) number is K152881.

When did SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM receive FDA 510(k) clearance?

SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM received FDA 510(k) clearance on 2016-04-01, under 510(k) number K152881.

Who is the listed applicant for SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM?

The FDA 510(k) record lists Spacelabs Healthcare, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM?

The FDA product code for SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM is DQK.

列明Spacelabs Healthcare, Ltd.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。

K212317Eclipse MINI 型号 98900 K211651Eclipse PRO K201921Spacelabs Lifescreen PRO 分析仪

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。