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510(k) Data Aggregation
K Number
K022448Device Name
WATER PURIFICATION SYSTEM
Manufacturer
Date Cleared
2003-05-28
(306 days)
Product Code
Regulation Number
876.5665Why did this record match?
Applicant Name (Manufacturer) :
PURITY WATER COMPANY OF SAN ANTONIO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Purify water used in hemodialysis treatment in dialysis centers/facilities having multiple treatment stations. Purify water used in hemodialysis treatment in hospital intensive care units, critical care units, pediatric intensive care units, and other acute care applications within a hospital setting.
Device Description
Water purification system for hemodialysis. The typical customized system is configured with booster pump, multimedia filtration, water softener, carbon filter, reverse osmosis, storage tank, ultra-filtration, deionization tanks, audible and visual alarms, and other components that purify water as a function of feed water quality and required capacity. The system product water complies with the AAMI Standard RD62:2001, Water Treatment Equipment for Hemodialysis Applications.
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