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Water Purification System For Hemodialysis

FDA 510(k)

Class II (US FDA 510(k))

510(k) K920186

by Better Water, Inc.

Identifiers

510(k) Number
K920186 FDA 510(k)
FDA Product Code
FIP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5665 FDA 510(k)
Regulation Number
876.5665 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Water Purification System for Hemodialysis is a device intended for use with a hemodialysis system. It functions to ensure the purity of water used in dialysis treatments.

This device is regulated as a Class 2 medical device under FDA 510(k) clearance. It is identified by product code FIP and regulation number 876.5665.

Frequently asked questions

What is the primary purpose of the Water Purification System for Hemodialysis?

This device is intended for use in conjunction with a hemodialysis system. Its specific function is to ensure the necessary level of water purity required for safe and effective dialysis treatments.

How is this device classified for regulatory purposes?

The system is regulated as a Class 2 medical device. It has received FDA 510(k) clearance, identified by product code FIP and regulation number 876.5665.

Who is the manufacturer of this water purification system?

This device is manufactured by Better Water, Inc., based in Smyrna, Tennessee.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Hemodialysis - Better Water, LLC, Complete water solutions for residential, industrial, commercial ..., Water Purification System for Hemodialysis - Better Water | FDA ..., WATER PURIFICATION SYSTEM FOR HEMODIALYSIS (K920186) — FDA 510 (k ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Better Water, Inc.

Sources (1)

  • FDA 510(k) K920186 24 fields · synced Sep 22, 2026