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FDA 510(k)

X-FLO 液体管理系统

K号: K210628 · 2021-11-04

申请人Thermedx, LLC
决定日期2021-11-04
产品代码HIG
咨询委员会OB 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同

器械摘要

X-FLO Fluid Management System is the device name listed in this FDA 510(k) record. The listed applicant is Thermedx, LLC. It received FDA 510(k) clearance on 2021-11-04 under 510(k) number K210628. The device is classified under product code HIG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the X-FLO Fluid Management System?

X-FLO Fluid Management System is a medical device that received FDA 510(k) clearance on 2021-11-04. The listed applicant is Thermedx, LLC. The 510(k) number is K210628.

When did X-FLO Fluid Management System receive FDA 510(k) clearance?

X-FLO Fluid Management System received FDA 510(k) clearance on 2021-11-04, under 510(k) number K210628.

Who is the listed applicant for X-FLO Fluid Management System?

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

What is the FDA product code for X-FLO Fluid Management System?

The FDA product code for X-FLO Fluid Management System is HIG.

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Thermedx, LLC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。

K172048FluidSmart

相关器械（代码：HIG）

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。

K261706Endomat Select (UP220)KARL STORZ SE & CO. KGK251273Asurys 流体管理系统Boston Scientific CorporationK240886Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205)Hologic, Inc.K201355Endomat Select, IBS Shaver Software, LicenseKarl Storz SE & CO. KGK180735Endomat SelectKarl Storz SE & CO. KGK180825Fluent Fluid Management SystemHologic, Inc.

官方来源

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