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510(k) Data Aggregation

    K Number
    K062970
    Device Name
    I-PAD
    Date Cleared
    2008-01-22

    (480 days)

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

    CU MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The i-PAD NF1200 is used to treat a person suffering from sudden cardiac arrest (SCA) and who exhibits symptoms of - No movement and no response when shaken . - No normal breathing .
    Device Description
    The i-PAD NF1200 is a semi-automated external defibrillator designed for minimally trained individuals. It provides simple and direct voice prompts and indications for a straightforward rescue operation. The i-PAD NF1200 needs the user to press its SHOCK button to deliver a defibrillating shock. During a resoue operation, it continuously acquires the electrocardiogram (ECG) of the patient. It also conducts arrhythmia detection continuously except during cardiopulmonary resuscitation (CPR). The timing and duration of the CPR are in accordance with the recommendations of the American Heart Association (AHA) 2005 Guidelines for CPR and Emergency Cardiovascular Care (ECC). The i-PAD NF1200 is lightweight and battery powered for maximum portability. Its battery pack has a capacity of 200 shocks (10 hours of operating time.) It delivers a 150-Joule biphasic truncated exponential shock waveform that it compensates for patient impedance by adjusting its timing parameter. If the user decides not to deliver a charge, the i-PAD NF1200 disarms itself by dumping the charge into an internal resistive load. The i-PAD NF1200 is capable of saving data and transmitting them to an external device. The i-PAD NF1200 conducts periodic (daily, weekly, and 28-day) self-tests, a battery insertion self-test, and self-tests during power-ON and run-time. It informs the user if an error is detected through audio and visual indicators.
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