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FDA 510(k)

MED-TECH 水系股份有限公司 過濾透析可交換碳壓縮罐

K 號：K153329 · 2016-08-04

申請人Med-Tech Water Systems, Inc.
決定日期2016-08-04
產品代碼FIP
諮詢委員會GU
決定相當於

器材摘要

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.

常見問題

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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

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