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510(k) Data Aggregation

    K Number
    K983196
    Device Name
    PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)
    Manufacturer
    TZ MEDICAL, INC.
    Date Cleared
    1999-09-15

    (369 days)

    Product Code
    DRO
    Regulation Number
    870.5550
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)

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

    TZ Medical adult disposable electrodes are used by trained professionals in hospitals, doctors offices and Emergency medical Services for adult low-energy defibrillation, transcutaneous pacing, cardioversion and monitoring.

    Device Description

    PadTac Adult Defibrillate/Cardiovert/Pace Pad Fac Addit Dollahilator - TZ Medical Inc.

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter for the "PADTAK Adult Defib/Cardiovert/Pace/Monitoring Electrodes." This document primarily indicates the FDA's finding of substantial equivalence to a predicate device and permits the marketing of the device. It does not contain information about the acceptance criteria or a study proving the device meets those criteria.

    Therefore, I cannot extract the requested information regarding performance, sample size, ground truth, or study details from the provided text.

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