UPT系列医用反渗透纯水处理系统
K号: K250514 · 2025-03-17
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决定日期2025-03-17
产品代码FIP
咨询委员会GU
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决定实质等同
器械摘要
UPT Series Medical RO Water Treatment System is the device name listed in this FDA 510(k) record. The listed applicant is Specialty Water Technologies, Inc.. It received FDA 510(k) clearance on 2025-03-17 under 510(k) number K250514. 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 UPT Series Medical RO Water Treatment System?
UPT Series Medical RO Water Treatment System is a medical device that received FDA 510(k) clearance on 2025-03-17. The listed applicant is Specialty Water Technologies, Inc.. The 510(k) number is K250514.
When did UPT Series Medical RO Water Treatment System receive FDA 510(k) clearance?
UPT Series Medical RO Water Treatment System received FDA 510(k) clearance on 2025-03-17, under 510(k) number K250514.
Who is the listed applicant for UPT Series Medical RO Water Treatment System?
The FDA 510(k) record lists Specialty Water Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for UPT Series Medical RO Water Treatment System?
The FDA product code for UPT Series Medical RO Water Treatment System 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。
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 AmericaK232953AquaBplus; AquaB LITEFresenius Medical Care Renal Therapies Group, LLCK223479AQUAbase nXB.Braun Medical, Inc.K231410RenaPure 内毒素滞留过滤器Evoqua Water Technologies, LLC
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。
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