FDA 510(k)

QMAPP放大器；QMAPP血流动力学监测系统；QMAPP PCM；QMAPP GO；QMAPP EP

K号: K170032 · 2017-09-08

决定日期2017-09-08

产品代码MWI

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

QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP is the device name listed in this FDA 510(k) record. The listed applicant is Fysicon BV. It received FDA 510(k) clearance on 2017-09-08 under 510(k) number K170032. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP?

QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP is a medical device that received FDA 510(k) clearance on 2017-09-08. The listed applicant is Fysicon BV. The 510(k) number is K170032.

When did QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP receive FDA 510(k) clearance?

QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP received FDA 510(k) clearance on 2017-09-08, under 510(k) number K170032.

Who is the listed applicant for QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP?

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

What is the FDA product code for QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP?

The FDA product code for QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP is MWI.

列明Fysicon BV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。

K241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)

官方来源

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