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510(k) Data Aggregation

    K Number
    K972418
    Device Name
    HEARTSTRAMELECTRODE ADAPTER(EA-XX SERIES)/HEARTSTRAM DEFIBRILLATION PADS WITH PREATTACHED ELECTRODE ADAPTER(DP-EAXX)
    Manufacturer
    HEARTSTREAM, INC.
    Date Cleared
    1997-09-25

    (90 days)

    Product Code
    MKJ
    Regulation Number
    870.5310
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEARTSTREAM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Heartstream Electrode Adapter: For use with Heartstream Defibrillators or Manual Defibrillators with a Quick-Combo® Connection System. For Defibrillation, Monitoring and Pacing. Heartstream External Defibrillation Pads with Preattached Electrode Adapter: For use with Heartstream Defibrillators or Manual Defibrillators with a Quick-Combo® Connection System. For Defibrillation, Monitoring and Pacing.
    Device Description
    Heartstream electrode adapters serve as an interface to allow Heartstream electrodes to be connected to various manual defibrillators for external cardiovascular pacing as well as monitoring and delivery of defibrillation shocks up to 360J. Heartstream electrode adapters are made of rigid thermoplastic material (or equivalent), with varying configurations depending upon the manual defibrillator for which they are designed. The adapters will be provided as reusable stand-alone accessories (to be used in conjunction with standard Heartstream electrodes) or preattached to a Heartstream electrode set, for single use.
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    K Number
    K955628
    Device Name
    FORE RUNNER EXTERNAL DEFIBRILLATOR/DEFIBRILLATOR PADS
    Manufacturer
    HEARTSTREAM, INC.
    Date Cleared
    1996-09-10

    (274 days)

    Product Code
    MKJ
    Regulation Number
    870.5310
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEARTSTREAM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ForeRunner external defibrillator, is indicated for use on victims of sudden cardiac arrest on whom an apparent lack of circulation is indicated by unconsciousness, absence of breathing and absence of detectable pulse.
    Device Description
    The ForeRunner external defibrillator is a semi-automatic external defibrillator incorporating voice prompts to advise the operator of the need to deliver a defibrillating shock. The device is designed to be used by emergency responders in the treatment of cardiac arrest. The device is portable, weighing approximately 4 pounds and measuring approximately 2.5"(H) x 8"(W) x 8.8"(D). The ForeRunner product line consists of the defibrillator, a disposable battery, a pack of disposable single use electrodes, carrying cases and other optional accessories, such as event recording data cards and event review software.
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