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510(k) Data Aggregation

    K Number
    K040904
    Device Name
    PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Date Cleared
    2004-09-16

    (162 days)

    Product Code
    NSA
    Regulation Number
    870.5310
    Why did this record match?
    Product Code :

    NSA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HeartStart Home Defibrillator should be used to treat someone who you think may be a victim of sudden cardiac arrest. A person in sudden cardiac arrest: - does not respond when shaken, and . - . is not breathing normally. If in doubt, apply the pads.
    Device Description
    The HeartStart Home Defibrillator was designed to be safe, easy and ready to use. Features of the HeartStart Home Defibrillator include self-testing and self-calibration, an impedance-compensating biphasic truncated exponential therapy waveform, a multiparameter ECG analysis system for determining if a shock is required, and an integrated human factors design to facilitate use by lay responders. A non-rechargeable lithium manganese dioxide battery powers the HeartStart Home Defibrillator with a minimum capacity of 90 shocks and 3 hours of operating time. The HeartStart Home Defibrillator monitors the progress of the rescue and issues voice instructions as appropriate, keeping pace with the user. The defibrillator incorporates a shock-delivery protocol that pauses at predefined intervals to allow users to deliver CPR, with CPR coaching available. Except during these pause intervals for CPR, the defibrillator continuously and automatically analyzes the patient's ECG to determine if a shock is needed. The defibrillator incorporates technologies that assess the ECG validity using both common mode and differential mode signals; these technologies were designed to ensure that a shock is not advised unless the defibrillator is applied to a patient in a shockable heart rhythm. The HeartStart Home Defibrillator utilizes the same biphasic, impedance-compensating exponential waveform used in previous-generation Philips AEDs. With the standard pads cartridge installed, the HeartStart Home Defibrillators delivers 150J shocks (nominal) after a shockable rhythm has been detected, and the user presses the shock button as instructed by the defibrillator. The HeartStart Home Defibrillator offers no manual-shock capability.
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