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FDA 510(k)

CloudCath 腹膜透析引流套装监控系统

K号: K212658 · 2022-02-09

申请人Cloudcath
决定日期2022-02-09
产品代码FKX
咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同

器械摘要

CloudCath Peritoneal Dialysis Drain Set Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Cloudcath. It received FDA 510(k) clearance on 2022-02-09 under 510(k) number K212658. The device is classified under product code FKX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CloudCath Peritoneal Dialysis Drain Set Monitoring System?

CloudCath Peritoneal Dialysis Drain Set Monitoring System is a medical device that received FDA 510(k) clearance on 2022-02-09. The listed applicant is Cloudcath. The 510(k) number is K212658.

When did CloudCath Peritoneal Dialysis Drain Set Monitoring System receive FDA 510(k) clearance?

CloudCath Peritoneal Dialysis Drain Set Monitoring System received FDA 510(k) clearance on 2022-02-09, under 510(k) number K212658.

Who is the listed applicant for CloudCath Peritoneal Dialysis Drain Set Monitoring System?

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

What is the FDA product code for CloudCath Peritoneal Dialysis Drain Set Monitoring System?

The FDA product code for CloudCath Peritoneal Dialysis Drain Set Monitoring System is FKX.

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

相关器械（代码：FKX）

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。

K250523Archimedes Pro 自动腹膜透析循环器 (3014-00000-1); Archimedes Standard 自动腹膜透析循环器 (3014-00000-3); Archimedes Pro 一次性管路套装 (3014-50000-1); Archimedes Standard 一次性管路套装 (3014-50000-3); Archimedes Pro Plus 一次性管路套装 (3014-50000-5)Simergent, LLCK243371Byonyks X-1 APD Cycler；Byonyks Automated PD Set DS-1Byonyks Pvt, Ltd.K220935数字透析诊所 - 智能透析助手（IDA）带医疗监督门户和IDA智能手机应用Iren-Medical, Ltd.K222318Fresenius Liberty Select 循环器Fresenius Medical Care Renal Therapies Group, LLCK212522Lilliput APD系统Fresenius Medical Care Renal Therapies Group, LLCK201867Homechoice Claria APD 系统，用于与 Homechoice Claria APD 系统配合使用的 Sharesource 连接平台Baxter Healthcare Corporation

官方来源

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