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510(k) Data Aggregation
K Number
K051620Device Name
MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES
Manufacturer
BETTER WATER, INC.
Date Cleared
2005-11-18
(154 days)
Product Code
FIP
Regulation Number
876.5665Why did this record match?
Applicant Name (Manufacturer) :
BETTER WATER, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Matrix Series Digital Reverse Osmosis Water Treatment System is an accessory device designed to safely and effectively provide water purification for use in hemodialysis applications. The water produced will meet the minimum water quality requirements as specified by Association for the Advancement of Medical Instrumentation (AAMI) standard RD62:2003 when used as directed. Dependent on feed water quality this unit may be used in conjunction with other approved water treatment components.
Device Description
The Matrix Series Digital Reverse Osmosis Water Treatment System is an accessory device that is intended for use with a hemodialysis applications and is intended to remove organic and inorganic substances and microbial contaminants from tap water used to dilute dialysate concentrate to form dialysate. The Matrix Series Digital Reverse Osmosis Water Treatment System will produce water as prescribed by the Association for the Advancement of Medical Instrumentation (AAMI) RD62:2003 standard provided adequate flow rate of the feed (tap) water and compliance with existing drinking water standards and proper pre-treatment.
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K Number
K992793Device Name
SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM
Manufacturer
BETTER WATER, INC.
Date Cleared
1999-11-16
(89 days)
Product Code
FIN
Regulation Number
876.5820Why did this record match?
Applicant Name (Manufacturer) :
BETTER WATER, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
THE INTENDED USE OF THESE DEVICES IS TO ALLOW THE HEMODIAL YSIS FACILITY TO MIX SODIUM BICARBONATE POWDER WITH PURIFIED WATER THAT MEETS AAMI STANDARDS FOR HEMODIAL YSIS TREATING TO BUIL ALLOW MIXED SOLUTION TO BE AUTOMATICALLY DELIVERED TO THE ALLYSIS MACHINES. IT IS ALSO INTENDED TO AUTOMATICALLY DELIVER A PRE-MIXED CONCENTRATE SOLUTION TO THE DIALYSIS MACHINE.
Device Description
The central mixing and delivery sodium bicarbonate system (tank) is filled with AAMI standard water, into which a specific amount of sodium bicarbonate powder is poured. It is then mixed in the tank, checked for proper solution, then delivered either manually, or automatically to each patient station on the treatment floor, where it is then mixed/diluted by the dialysis machine for the intended treatment.
The central delivery concentrate system works much the same way, with the exception that the solution is not mixed in the system provided by Better Water, Inc. The solution is either pre-mixed and bulk transferred, or it is mixed in a separate piece of equipment, and then transferred to the bulk storage and delivery system, provided by Better Water, Inc.
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K Number
K954928Device Name
PORTABLE REVERSE OSMOSIS MACHINE
Manufacturer
BETTER WATER, INC.
Date Cleared
1996-01-24
(90 days)
Product Code
FIP
Regulation Number
876.5665Why did this record match?
Applicant Name (Manufacturer) :
BETTER WATER, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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