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    K Number
    K001631
    Device Name
    CORTEX METAMAX
    Manufacturer
    CORTEX BIOPHYSIK GMBH
    Date Cleared
    2001-02-22

    (272 days)

    Product Code
    BZC
    Regulation Number
    868.1880
    Why did this record match?
    Applicant Name (Manufacturer) :

    CORTEX BIOPHYSIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993641
    Device Name
    METALYZER, MODEL 2; METALYZER, MODEL 3
    Manufacturer
    CORTEX BIOPHYSIK GMBH
    Date Cleared
    2000-12-14

    (413 days)

    Product Code
    BTY, SEP
    Regulation Number
    868.1890
    Why did this record match?
    Applicant Name (Manufacturer) :

    CORTEX BIOPHYSIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CORTEX METALYZER pulmonary function stationary test system is a device which monitors the cardio-respiratory functions during stress testing, rehabilitation, sports medicine and other related activities. The METALYZER system provides predictive nulmonary function values using the monitored and derived parameters. This device is for use in a laboratory or facility setting and may be used with adults and children over the age of 14 years.
    Device Description
    The CORTEX METALYZER metabolic test system is a stationary device, which can monitor parameters during laboratory testing or simulated conditions. The device is comparable to the Jaeger Oxycon Alpha system. The device is software driven. Adequate software testing with respect to the new IEC 601-1-4 has been conducted on the device. The device is electrically operated.
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