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510(k) Data Aggregation

    K Number
    K970674
    Device Name
    G.E.M. WATER SYSTEMS, INTERNATIONAL
    Manufacturer
    G.E.M. WATER SYSTEMS
    Date Cleared
    1997-11-19

    (268 days)

    Product Code
    FIN
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    G.E.M. WATER SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THE INTENDED USE OF THESE DEVICES IS ALLOW THE HEMODIALYSIS FACILITY TO MIX SODIUM BICARBONATE POWDER WITH PRUIFIED WATER THAT MEETS AAMI STANDARDS FOR HEMODIALYSIS TREATMENT, AND ALLOW THE MIXED SOLUTION TO BE AUTOMATICALLY DELIVERED TO THE DIALYSIS MACHINES.
    Device Description
    Not Found
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    K Number
    K944493
    Device Name
    REVERSE OSMOSIS SYSTEM
    Manufacturer
    G.E.M. WATER SYSTEMS
    Date Cleared
    1996-02-20

    (525 days)

    Product Code
    FIP
    Regulation Number
    876.5665
    Why did this record match?
    Applicant Name (Manufacturer) :

    G.E.M. WATER SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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