FDA 510(k)

日立医電 SVM-7200 系列生命体征监测仪

K号: K190468 · 2019-05-28

决定日期2019-05-28

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

Nihon Kohden SVM-7200 Series Vital Signs Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden Corporation. It received FDA 510(k) clearance on 2019-05-28 under 510(k) number K190468. 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 Nihon Kohden SVM-7200 Series Vital Signs Monitor?

Nihon Kohden SVM-7200 Series Vital Signs Monitor is a medical device that received FDA 510(k) clearance on 2019-05-28. The listed applicant is Nihon Kohden Corporation. The 510(k) number is K190468.

When did Nihon Kohden SVM-7200 Series Vital Signs Monitor receive FDA 510(k) clearance?

Nihon Kohden SVM-7200 Series Vital Signs Monitor received FDA 510(k) clearance on 2019-05-28, under 510(k) number K190468.

Who is the listed applicant for Nihon Kohden SVM-7200 Series Vital Signs Monitor?

FDA 510(k)记录中列出Nihon Kohden Corporation为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Nihon Kohden SVM-7200 Series Vital Signs Monitor?

The FDA product code for Nihon Kohden SVM-7200 Series Vital Signs Monitor is MWI.

列明Nihon Kohden Corporation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。

K251641GF-310R 多气体单元（GF-310R）K260747YP-710T系列血压计袖带；YP-840T系列一次性袖带 K251366EEG-1260A Neurofax系统（EEG-1260A）；JE-940A EEG放大器单元（JE-940A）；LS-940A光刺激器（LS-940A）K243956TG-980P CO2 传感器套件 (TG-980P); TG-980P1 CO2 传感器套件 (TG-980P1)K223567CNS-2101 中央监测仪 K220976Life Scope PT BSM-1700系列床旁监护仪

查看所有 19 个设备 →

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。