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510(k) Data Aggregation

    K Number
    K022078
    Device Name
    SOLA, COUNTER-PULSATION, MODEL SECP-S
    Manufacturer
    SOLA MEDICAL DEVICES, LLC
    Date Cleared
    2003-01-10

    (198 days)

    Product Code
    DRN
    Regulation Number
    870.5225
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOLA MEDICAL DEVICES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device can be used for the treatment of: The Sola Counter-Pulsating device is a non invasive external counterpulsation device intended for use in the treatment of patients with stable angina pectoris, acute myocardial infarction, cardiogenic shock and congestive heart failure.
    Device Description
    The Sola Counter-Pulsating device is a non invasive external counterpulsation device.
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