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You are here: Home / Regulatory/Compliance / Food & Drug Administration (FDA) / 510(k) / Nephros wins 510(k) for HydraGuard bacterial water filter

Nephros wins 510(k) for HydraGuard bacterial water filter

December 27, 2016 By Fink Densford Leave a Comment

NephrosNephros (OTC:NEPH) said today it won FDA 510(k) clearance for its water ionizer review designed for water bacterial filtration.

The River Edge, N.J.-based company said its HydraGuard 10″ UltraFilter is designed to provide 6 months of bacterial protection and filtration for potable water sources such as endoscope re-processors, surgical humidifiers and ice machines.

“The HydraGuard is a powerful addition to our infection control portfolio, with the potential to significantly aid our customers in their constant battle against Legionella and other water borne pathogens. With its 5 nanometer protection, its six month life, and its low annual cost versus competitive products, we believe the HydraGuard will set a new standard in performance and customer expectations,” prez & CEO Daron Evans said in a press release.

In May, Nephros said it inked a distribution agreement with CS Medical to distribute Nephros’ DSU-H ultrafilter as an option with CS Medical’s TD 100 automated trans-esophageal echocardiogram probe disinfector.

The DSU-H filter from Nephros  has FDA 510(k) clearance and is designed to provide ultrapure water as an aid in infection prevention and control, CS Medical said.

Filed Under: 510(k), Dialysis, Food & Drug Administration (FDA), Regulatory/Compliance, Sterilization / Calibration Tagged With: Nephros

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