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510(k) Data Aggregation

    K Number
    K020909
    Device Name
    HDM99
    Manufacturer
    IBP INSTRUMENTS GMBH
    Date Cleared
    2002-05-22

    (63 days)

    Product Code
    FIZ
    Regulation Number
    876.5820
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K992431
    Why did this record match?
    Device Name :

    HDM99

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary and FDA clearance letter for the HDM99 device, focusing on its substantial equivalence to a predicate device based on general safety and effectiveness standards, not specific performance criteria from a dedicated study.

    Therefore, I cannot provide the requested information.

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