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510(k) Data Aggregation

    K Number
    K992706
    Device Name
    GALIX GBI -3S-LP
    Manufacturer
    GALIX BIOMEDICAL INSTRUMENTATION, INC.
    Date Cleared
    2001-03-15

    (581 days)

    Product Code
    MLO
    Regulation Number
    870.2800
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Galix GBI-3S-LP Digital Holter Recorder is intended primarily as a 24 hour ECG Ambulatory Holter Recorder. However the unit has the ability to record up to 10 minutes of Very High Resolution ECG, at a sampling rate of 1000 samples per second. The ECG data stored is then analyzed with the Late Potential Software, Warning: The clinical significance of Late Potential measures should be determined by a qualified physician.

    Device Description

    GALIX GBI - 3S - LP Digital Holter Recorder

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA to Galix Biomedical Instrumentation, Inc. for their GALIX GBI-3S-LP device. It primarily focuses on regulatory approval and does not contain detailed information about acceptance criteria, specific performance studies, sample sizes, or ground truth establishment for the device's analytical capabilities.

    Therefore, I cannot provide the requested information as it is not present in the given text. The letter only states that the device is "substantially equivalent" to marketed predicate devices and outlines general regulatory compliance requirements. It does not include the detailed technical study information that would be necessary to answer the questions you've posed.

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