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510(k) Data Aggregation

    K Number
    K992431
    Device Name
    NEO-2 METER
    Manufacturer
    AUTOMATA INSTRUMENTATION, INC.
    Date Cleared
    1999-10-13

    (84 days)

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

    AUTOMATA INSTRUMENTATION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NEO-2 Meter may be used by hemodialysis personnel to test conductivity, temperature, pressure, and pH of the dialysate solution used with hemodialysis delivery systems. The NEO-2 Meter may also be used to test the conductivity/temperature and pH of acid and sodium bicarbonate dialysate concentrates and water used in hemodialysis applications.
    Device Description
    Not Found
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    K Number
    K981294
    Device Name
    ODYSSEY INSTRUMENTATION SYSTEM
    Manufacturer
    AUTOMATA INSTRUMENTATION, INC.
    Date Cleared
    1998-07-08

    (90 days)

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

    AUTOMATA INSTRUMENTATION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ODYSSEY Instrumentation System is intended for use by hemodialysis professionals to measure the conductivity, temperature, pH, and pressure of the dialysate solution associated with hemodialysis delivery systems. Water purification specialists may also use the ODYSSEY Instrumentation System to verify proper characteristics of the water used in hemodialysis. These parameters are key indicators of system performance that require periodic monitoring and adjusting to maintain safe and effective hemodialysis systems.
    Device Description
    Not Found
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    K Number
    K974127
    Device Name
    HYDRA METER
    Manufacturer
    AUTOMATA INSTRUMENTATION, INC.
    Date Cleared
    1997-12-19

    (46 days)

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

    AUTOMATA INSTRUMENTATION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HYDRA Meter is a hand-held, multi-test instrument intended for use by water purification specialists to measure the conductivity, resistivity, total dissolved solids (TDS), pH, and temperature of water used in hemodialysis. The HYDRA Meter may also be used to verify proper functioning of the water system's in-line conductivity, resistivity and pH meters.
    Device Description
    The HYDRA Meter is a hand-held, multi-test instrument.
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