SureSigns VS3；SureSigns VS4
K号: K163649 · 2017-03-31
广告
决定日期2017-03-31
产品代码DSJ
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
SureSigns VS3; SureSigns VS4 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 2017-03-31 under 510(k) number K163649. The device is classified under product code DSJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SureSigns VS3; SureSigns VS4?
SureSigns VS3; SureSigns VS4 is a medical device that received FDA 510(k) clearance on 2017-03-31. The listed applicant is Philips Medical Systems. The 510(k) number is K163649.
When did SureSigns VS3; SureSigns VS4 receive FDA 510(k) clearance?
SureSigns VS3; SureSigns VS4 received FDA 510(k) clearance on 2017-03-31, under 510(k) number K163649.
Who is the listed applicant for SureSigns VS3; SureSigns VS4?
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 SureSigns VS3; SureSigns VS4?
The FDA product code for SureSigns VS3; SureSigns VS4 is DSJ.
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。
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 BX100K183387M3290B Patient Information Center iX
相关器械（代码：DSJ）
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。
广告