EON 便携式反渗透水净化系统
K号: K171099 · 2018-01-05
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申请人Cantel
决定日期2018-01-05
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
EON Portable Reverse Osmosis Water Purification System is the device name listed in this FDA 510(k) record. The listed applicant is Cantel. It received FDA 510(k) clearance on 2018-01-05 under 510(k) number K171099. 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 EON Portable Reverse Osmosis Water Purification System?
EON Portable Reverse Osmosis Water Purification System is a medical device that received FDA 510(k) clearance on 2018-01-05. The listed applicant is Cantel. The 510(k) number is K171099.
When did EON Portable Reverse Osmosis Water Purification System receive FDA 510(k) clearance?
EON Portable Reverse Osmosis Water Purification System received FDA 510(k) clearance on 2018-01-05, under 510(k) number K171099.
Who is the listed applicant for EON Portable Reverse Osmosis Water Purification System?
The FDA 510(k) record lists Cantel as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EON Portable Reverse Osmosis Water Purification System?
The FDA product code for EON Portable Reverse Osmosis Water Purification 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 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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