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510(k) Data Aggregation

    K Number
    K012264
    Device Name
    MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC
    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
    Why did this record match?
    Device Name :

    MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Replacement battery pack for MARQUETTE MAC 8, MAC PERSONAL & MAC STRESS 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 for Marquette Mac8, and Mac Stress

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for a replacement battery pack. It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device. Therefore, I cannot generate the requested table and study details.

    The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This indicates that the clearance is based on substantial equivalence to existing devices, not on a new clinical study demonstrating specific performance metrics against pre-defined acceptance criteria for a novel device or AI algorithm.

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