AmeriWater MediQA 反渗透系统 (MSP3HF)
K号: K223656 · 2023-02-13
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决定日期2023-02-13
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
AmeriWater MediQA Reverse Osmosis System (MSP3HF) is the device name listed in this FDA 510(k) record. The listed applicant is AmeriWater, LLC. It received FDA 510(k) clearance on 2023-02-13 under 510(k) number K223656. 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 AmeriWater MediQA Reverse Osmosis System (MSP3HF)?
AmeriWater MediQA Reverse Osmosis System (MSP3HF) is a medical device that received FDA 510(k) clearance on 2023-02-13. The listed applicant is AmeriWater, LLC. The 510(k) number is K223656.
When did AmeriWater MediQA Reverse Osmosis System (MSP3HF) receive FDA 510(k) clearance?
AmeriWater MediQA Reverse Osmosis System (MSP3HF) received FDA 510(k) clearance on 2023-02-13, under 510(k) number K223656.
Who is the listed applicant for AmeriWater MediQA Reverse Osmosis System (MSP3HF)?
The FDA 510(k) record lists AmeriWater, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AmeriWater MediQA Reverse Osmosis System (MSP3HF)?
The FDA product code for AmeriWater MediQA Reverse Osmosis System (MSP3HF) 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 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
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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