EON可攜式逆渗透水淨化系統
K 號：K171099 · 2018-01-05
廣告
器材摘要
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.
常見問題
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.
相關臨床試驗
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
相關器械（代碼：FIP）
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
K250471AquaC UNO HFresenius Medical Care Renal Therapies Group, LLCK251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLCK252181AquaAFresenius Medical Care North AmericaK250514UPT系列醫療RO水處理系統Specialty Water Technologies, Inc.K232953AquaBplus; AquaB LITEFresenius Medical Care Renal Therapies Group, LLCK223479AQUAbase nXB.Braun Medical, Inc.
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
廣告