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510(k) Data Aggregation

    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
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    CORTEX BIOPHYSIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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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
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K980094
    Why did this record match?
    Applicant Name (Manufacturer) :

    CORTEX BIOPHYSIK GMBH

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

    AI/ML Overview

    The provided text describes a 510(k) summary for the CORTEX METALYZER, a metabolic test system. However, it does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

    The document primarily focuses on:

    • Device Description and Comparison: Stating that the CORTEX METALYZER is a stationary device that monitors parameters during laboratory testing, comparable to the Jaeger Oxycon Alpha system. It highlights software, electrical operation, and component similarities/differences (e.g., oxygen sensor type).
    • Intended Use: For monitoring cardio-respiratory functions during stress testing, rehabilitation, sports medicine, and other related activities, providing predictive pulmonary function values, and being used in a laboratory/facility setting for adults and children over 14.
    • Substantial Equivalence: The FDA's letter confirming that the device is substantially equivalent to a legally marketed predicate device (K980094).

    Therefore, I cannot populate the requested table and details because the necessary information is not present in the given text.

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