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510(k) Data Aggregation

    K Number
    K012263
    Device Name
    MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024
    Manufacturer
    NATIONAL CUSTOM ENT., INC.
    Date Cleared
    2001-10-10

    (84 days)

    Product Code
    DPS
    Regulation Number
    870.2340
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    K040202
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Replacement battery pack for MARQUETTE EAGLE MONITOR MODEL 4000 This battery will be shipped to biomedical equipment technicians and or customers who request a replacement battery for the particular device(s) listed above

    Device Description

    Replacement battery pack for MARQUETTE EAGLE MONITOR MODEL 4000

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for a replacement battery pack for a Marquette Eagle Monitor. It does not contain any information about acceptance criteria, device performance, study details, or ground truth related to an AI/ML powered device.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval for a replacement part, not the performance of an AI system.

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