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510(k) Data Aggregation

    K Number
    K201765
    Device Name
    SmartHDM-510 System
    Manufacturer
    Mesa Laboratories, Inc.
    Date Cleared
    2020-09-02

    (65 days)

    Product Code
    FIZ
    Regulation Number
    876.5820
    Why did this record match?
    Product Code :

    FIZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SmartHDM-510 system may be used by hemodialysis personnel to test the conductivity, temperature, pH and flow of the dialysate solution used with hemodialysis delivering systems. The SmartHDM-510 system may also be used to test the conductivity/temperature and pH of acid and sodium bicarbonate dialysate concentrates and water used in hemodialysis applications. The intended use is limited to periodic use for installation and maintenance of hemodialysis delivering systems and does not include the daily monitoring of hemodialysis delivering systems prior to treatment.
    Device Description
    The SmartHDM-510 System is designed for the installation and maintenance of hemodialysis delivering systems. The system consists of different sensors and sensor-modules to measure conductivity, temperature, pressure, pH and flow and an Android operating system based display module with SmartHDM-510 App. The SmartHDM-510 system consists of: - HDU-Sensors for Conductivity/Temperature, Pressure, pH and flow - HDM-Sensor Modules for Conductivity/Temperature, Pressure, - 90XL-Sensors for Conductivity/Temperature, Pressure and pH - Android-based Display Module with SmartHDM-510 App.
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    K Number
    K150657
    Device Name
    Phoenix XL Dialysate Meter
    Manufacturer
    Mesa Laboratories, Inc.
    Date Cleared
    2015-09-21

    (192 days)

    Product Code
    FIZ
    Regulation Number
    876.5820
    Why did this record match?
    Product Code :

    FIZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is designed for use by hemodialysis professionals to verify the conductivity, temperature, and pH of solutions in the hemodialysis setting.
    Device Description
    This device is a hand-held battery powered, multi-test meter designed for use by hemodialysis professionals to measure the conductivity, temperature and pH of Dialysate solutions associated with the dialysis treatment. The unit houses the conductivity cell, electronic circuitry and digital display. A syringe attaches to the unit with luer connectors. When pulled, the syringe creates a vacuum and draws solution through the conductivity cell for measurement. The conductivity cell contains the conductivity electrodes, a thermistor, and a pH electrode. A 3.6 volt battery provides power.
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    K Number
    K050812
    Device Name
    90XL INSTRUMENTATION SYSTEM
    Manufacturer
    MESA LABORATORIES, INC.
    Date Cleared
    2005-05-05

    (35 days)

    Product Code
    FIZ
    Regulation Number
    876.5820
    Why did this record match?
    Product Code :

    FIZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 90XL Dialysis Meter 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 90XL 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 documentation for effective hemodialysis systems.
    Device Description
    Not Found
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    K Number
    K020908
    Device Name
    HDM97
    Manufacturer
    IBP INSTRUMENTS GMBH
    Date Cleared
    2002-05-22

    (63 days)

    Product Code
    FIZ
    Regulation Number
    876.5820
    Why did this record match?
    Product Code :

    FIZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HDM97 may be used by hemodialysis personnel to test the conductivity, temperature, pressure and pH of the dialysate solution used with hemodialysis delivering systems. The HDM97 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
    The HDM97 was developed in 1997 to test conductivity/temperature, pressure and pH in hemodialysis applications. The HDM97 has a large, easy readable 3½ Digital Liquid Crystal Display. It comes with a waterproof key membrane. All selections are done with 9 key's including On and Off. The software is designed to be logical and easy to use for the user either safe and precise in measurement.
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    K Number
    K020909
    Device Name
    HDM99
    Manufacturer
    IBP INSTRUMENTS GMBH
    Date Cleared
    2002-05-22

    (63 days)

    Product Code
    FIZ
    Regulation Number
    876.5820
    Why did this record match?
    Product Code :

    FIZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HDM99 may be used by hemodialysis personnel to test the conductivity, temperature, pressure, pH and flow of the dialysate solution used with hemodialysis delivering systems. The HDM99 may also be used to test the conductivity/temperature and pH of acid and sodium bicarbonate dialysate concentrates and water used in hemodialysis applications. The HDM99 may also be used to test the voltage and alternating signals in hemodialysis delivering systems.
    Device Description
    The HDM99 was developed in 1990. The first version was called HDM90. 1996 we added the Flow measurement. From this time on the device was called HDM96. 1999 we increased accuracy and software functionality. The device was renamed to HDM99. The HDM99 has a large, easy readable Graphic Liquid Crystal Display. It comes with a waterproof key membrane. All selections are done with 22 key's including On and Off. The software is designed to be logical and easy to use for the user either safe and precise in measurement. The HDM99 has a RS232-Interface for the possibility to collect and visualize data on a PC. The software is designed to be logical and easy to use for the user either safe and precise in measurement.
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    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?
    Product Code :

    FIZ

    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?
    Product Code :

    FIZ

    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
    K955298
    Device Name
    PHOENIX DIALYSATE METER
    Manufacturer
    AUTOMATA MEDICAL INSTRUMENTATION, INC.
    Date Cleared
    1996-02-29

    (101 days)

    Product Code
    FIZ
    Regulation Number
    876.5820
    Why did this record match?
    Product Code :

    FIZ

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