FDA 510(k) Applications for Medical Device Product Code "NHV"
(System, Water Purification, General Medical Use)

FDA 510(k) Number Applicant Device Name Decision Date
K191563 aqua-tools FILTRAY 2G Disposable Water Filters 10/25/2019
K173164 Ecolab Inc. Ecolab POU Water Filter 06/29/2018
K182164 Ecolab Inc. Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower Wand 03/29/2019
K153784 Evoqua Water Technologies, LLC NOSOGARD FILTERS 10/21/2016
K222727 i3 Membrane GmbH i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S) 06/02/2023
K153084 NEPHROS INC. Nephros S100 04/08/2016
K161467 NEPHROS INC. HydraGuard 10 UltraFilter 12/22/2016
K141731 NEPHROS, INC. NEPHROS DSU-H, NEPHROS SSU-H 10/24/2014
K163609 PALL INTERNATIONAL SARL Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet) 06/01/2017
K153434 PALL INTERNATIONAL, SARL Pall-Aquasafe Water Filter 06/10/2016
K012716 PRISMEDICAL CORP. MAINSTREAM WATER PURIFICATION DEVICE 05/07/2002


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