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510(k) K163609

Device
Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet)
Applicant
PALL INTERNATIONAL SARL
510(k) number
K163609
Product code
NHV  
Decision
Substantially Equivalent (SESE)
Decision date
2017-06-01
Date received
2016-12-22
Regulation
876.5665
Classification name
System, Water Purification, General Medical Use
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Karen Peterson-Doyle
Address
Ave. De Tivoli 3 Fribourg CH CH-1700 CH-1700

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NHV  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K222727i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)I3 Membrane GmbH2023-06-02
K191563FILTRAY 2G Disposable Water FiltersAqua-Tools2019-10-25
K182164Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower WandEcolab, Inc.2019-03-29
K173164Ecolab POU Water FilterEcolab, Inc.2018-06-29
K161467HydraGuard 10 UltraFilterNephros, Inc.2016-12-22
K153784NOSOGARD FILTERSEvoqua Water Technologies, LLC2016-10-21
K153434Pall-Aquasafe Water FilterPall International Sarl2016-06-10
K153084Nephros S100Nephros, Inc.2016-04-08
K141731NEPHROS DSU-H, NEPHROS SSU-HNephros, Inc.2014-10-24
K012716MAINSTREAM WATER PURIFICATION DEVICEPrismedical Corp.2002-05-07

Legacy Summary#

summary

FDA Review#

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