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FDA 510(k)

MED-TECH透析用水系统可更换活性炭罐

K号: K153329 · 2016-08-04

申请人Med-Tech Water Systems, Inc.
决定日期2016-08-04
产品代码FIP
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

MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis is the device name listed in this FDA 510(k) record. The listed applicant is Med-Tech Water Systems, Inc.. It received FDA 510(k) clearance on 2016-08-04 under 510(k) number K153329. The device is classified under product code FIP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis?

MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis is a medical device that received FDA 510(k) clearance on 2016-08-04. The listed applicant is Med-Tech Water Systems, Inc.. The 510(k) number is K153329.

When did MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis receive FDA 510(k) clearance?

MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis received FDA 510(k) clearance on 2016-08-04, under 510(k) number K153329.

Who is the listed applicant for MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis?

The FDA 510(k) record lists Med-Tech Water Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis?

The FDA product code for MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis is FIP.

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：FIP）

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。

K250471AquaC UNO HFresenius Medical Care Renal Therapies Group, LLCK251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLCK252181AquaAFresenius Medical Care North AmericaK250514UPT系列医用反渗透纯水处理系统Specialty Water Technologies, Inc.K232953AquaBplus; AquaB LITEFresenius Medical Care Renal Therapies Group, LLCK223479AQUAbase nXB.Braun Medical, Inc.

官方来源

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