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FDA 510(k)

FILTRAY 2G 一次性水過濾器

K 號：K191563 · 2019-10-25

申請人Aqua-Tools
決定日期2019-10-25
產品代碼NHV
諮詢委員會GU
決定相當於

器材摘要

FILTRAY 2G Disposable Water Filters is the device name listed in this FDA 510(k) record. The listed applicant is Aqua-Tools. It received FDA 510(k) clearance on 2019-10-25 under 510(k) number K191563. The device is classified under product code NHV. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FILTRAY 2G Disposable Water Filters?

FILTRAY 2G Disposable Water Filters is a medical device that received FDA 510(k) clearance on 2019-10-25. The listed applicant is Aqua-Tools. The 510(k) number is K191563.

When did FILTRAY 2G Disposable Water Filters receive FDA 510(k) clearance?

FILTRAY 2G Disposable Water Filters received FDA 510(k) clearance on 2019-10-25, under 510(k) number K191563.

Who is the listed applicant for FILTRAY 2G Disposable Water Filters?

The FDA 510(k) record lists Aqua-Tools as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FILTRAY 2G Disposable Water Filters?

The FDA product code for FILTRAY 2G Disposable Water Filters is NHV.

相關臨床試驗

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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：NHV）

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。

K261470QF10E.A.M Benelux B.VK222727i3 ONE (203100-S)；i3 TWO connect (203200-S)；i3 TWO direct (203300-S)I3 Membrane GmbHK182164Ecolab POU 水濾器噴嘴出口，Ecolab POU 水濾器噴嘴出口，Ecolab POU 水濾器淋浴桿Ecolab, Inc.K173164Ecolab POU 水濾器Ecolab, Inc.K163609Pall Q點水過濾膠囊（淋浴），Pall Q點水過濾膠囊（水龍頭）Pall International SarlK161467HydraGuard 10 超濾器Nephros, Inc.

官方來源

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