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FDA 510(k)

DOUBLEFLO进出流泵，配件和管路套装

K号: K221919 · 2023-03-09

申请人Hemodia Sas
决定日期2023-03-09
产品代码HRX
咨询委员会OR 请注意，由于原文中未提供具体的医疗设备监管文本，以下是一个示例翻译，您可以根据实际文本进行调整： --- 产品名称：[产品名称] 公司名称：[公司名称] 根据FDA 510(k)预市场批准程序，[产品名称]已获得批准，用于[产品用途描述]。 产品注册号：[注册号] PMA编号：[PMA编号] 临床试验编号（NCT）：[NCT编号] PubMed ID（PMID）：[PMID编号] 更多信息请访问以下链接： [URL] --- 请将上述示例中的[产品名称]、[公司名称]、[注册号]、[PMA编号]、[NCT编号]、[PMID编号]和[URL]替换为实际的文本内容。
决定实质等同

器械摘要

DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets is the device name listed in this FDA 510(k) record. The listed applicant is Hemodia Sas. It received FDA 510(k) clearance on 2023-03-09 under 510(k) number K221919. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets?

DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets is a medical device that received FDA 510(k) clearance on 2023-03-09. The listed applicant is Hemodia Sas. The 510(k) number is K221919.

When did DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets receive FDA 510(k) clearance?

DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets received FDA 510(k) clearance on 2023-03-09, under 510(k) number K221919.

Who is the listed applicant for DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets?

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

What is the FDA product code for DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets?

The FDA product code for DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets is HRX.

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Hemodia Sas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。

K203480DOUBLEFLO系统K192921Zeos Aqua Vision 泵和管

相关器械（代码：HRX）

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。

K260203富勒椎体成形术球囊导管Beijing Fule Science & Technology Development Co., Ltd.K254103霍普金斯关节镜望远镜Karl Storz SE & CO. KGK252790数字ClarusScope系统及数字NeuroPEN系统Clarus Medical, LLCK253523Freedom DS®减压系统Spinal SimplicityK252546Vantage™ 腰椎减压套装Allevion Medical, LLCK253217MiiS Horus 眼镜镜片（EJA 100）；MiiS Horus 内窥镜显示系统 - 平板（EDS 500）；MiiS Horus 内窥镜显示系统 - 视频盒（EVS 700）Medimaging Integrated Solution, Inc (Miis)

官方来源

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