FDA 510(k)

CareEvent 包括 CareEvent 移动应用程序附件

K号: K161164 · 2016-06-24

决定日期2016-06-24

产品代码MSX

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

CareEvent inclusive of the CareEvent Mobile Application accessory is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems. It received FDA 510(k) clearance on 2016-06-24 under 510(k) number K161164. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CareEvent inclusive of the CareEvent Mobile Application accessory?

CareEvent inclusive of the CareEvent Mobile Application accessory is a medical device that received FDA 510(k) clearance on 2016-06-24. The listed applicant is Philips Medical Systems. The 510(k) number is K161164.

When did CareEvent inclusive of the CareEvent Mobile Application accessory receive FDA 510(k) clearance?

CareEvent inclusive of the CareEvent Mobile Application accessory received FDA 510(k) clearance on 2016-06-24, under 510(k) number K161164.

Who is the listed applicant for CareEvent inclusive of the CareEvent Mobile Application accessory?

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

What is the FDA product code for CareEvent inclusive of the CareEvent Mobile Application accessory?

The FDA product code for CareEvent inclusive of the CareEvent Mobile Application accessory is MSX.

列明Philips Medical Systems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。

K212704Philips EPIQ诊断超声系统，Philips Affiniti诊断超声系统 K211597EPIQ 系列诊断超声系统, Affiniti 系列诊断超声系统 K210560Page Writer TC20 心电图机，Page Writer TC30 心电图机，Page Writer TC50 心电图机，Page Writer TC70 心电图机 K191738PageWriter TC20 心电图机，PageWriter TC30 心电图机，PageWriter TC50 心电图机，PageWriter TC70 心电图机 K192875Philips Biosensor BX100 K183387M3290B Patient Information Center iX

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