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510(k) K191563

Device
FILTRAY 2G Disposable Water Filters
Applicant
Aqua-tools
510(k) number
K191563
Product code
NHV  
Decision
Substantially Equivalent (SESE)
Decision date
2019-10-25
Date received
2019-06-13
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
Virginie S. Grondin
Address
26, Rue Charles Edouard Jeanneret Poissy FR 78300 78300

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
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
K163609Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet)Pall International Sarl2017-06-01
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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