PlasmaFlow
K号: K160318 · 2016-04-01
广告
决定日期2016-04-01
产品代码JOW
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
PlasmaFlow is the device name listed in this FDA 510(k) record. The listed applicant is Manamed, Inc.. It received FDA 510(k) clearance on 2016-04-01 under 510(k) number K160318. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the PlasmaFlow?
PlasmaFlow is a medical device that received FDA 510(k) clearance on 2016-04-01. The listed applicant is Manamed, Inc.. The 510(k) number is K160318.
When did PlasmaFlow receive FDA 510(k) clearance?
PlasmaFlow received FDA 510(k) clearance on 2016-04-01, under 510(k) number K160318.
Who is the listed applicant for PlasmaFlow?
The FDA 510(k) record lists Manamed, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PlasmaFlow?
The FDA product code for PlasmaFlow is JOW.
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Manamed, Inc.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。
相关器械（代码：JOW）
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。
K261807顺序循环器（SC-4004-DL，SC-4008-DL）Bio Compression Systems, Inc.K254217AerloomEvolym, LLCK253555Flexitouch® Plus 高级气动压缩系统Tactile MedicalK253386DVT 服装Vistar Medical Supplies Co., Ltd.K250242压缩治疗设备（LGT-2202DVT）Guangzhou Longest Medical Technology Co., Ltd.K254267NanoPress 760A-BT (760A-BT)Mego Afek , Ltd.
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