FDA 510(k)

M3290B Patient Information Center iX

K号: K183387 · 2019-08-06

决定日期2019-08-06

产品代码MHX

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

M3290B Patient Information Center iX 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 2019-08-06 under 510(k) number K183387. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the M3290B Patient Information Center iX?

M3290B Patient Information Center iX is a medical device that received FDA 510(k) clearance on 2019-08-06. The listed applicant is Philips Medical Systems. The 510(k) number is K183387.

When did M3290B Patient Information Center iX receive FDA 510(k) clearance?

M3290B Patient Information Center iX received FDA 510(k) clearance on 2019-08-06, under 510(k) number K183387.

Who is the listed applicant for M3290B Patient Information Center iX?

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 M3290B Patient Information Center iX?

The FDA product code for M3290B Patient Information Center iX is MHX.

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 K180017MX40 版本 C.01

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相关器械（代码：MHX）

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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