LogoFDA 510(k) Search
Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K021340
    Device Name
    AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE
    Manufacturer
    EXTERNAL COUNTERPULSATION LAB
    Date Cleared
    2003-01-30

    (279 days)

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

    EXTERNAL COUNTERPULSATION LAB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AECP-A is a non-invasive external counterpulsation device for treatment of patients suffering from stable or unstable angina pectoris, acute myocardial infarction and cardiogenic shock
    Device Description
    Automatic External Counterpulsation Device
    Ask a Question
    K Number
    K012141
    Device Name
    AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE
    Manufacturer
    EXTERNAL COUNTERPULSATION LAB
    Date Cleared
    2001-10-25

    (107 days)

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

    EXTERNAL COUNTERPULSATION LAB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AECP-A is a non-invasive external couterpulsation device for The ALCI - 11 to a not suffering from stable or unstable angina pectoris, acute myocardial infarction and cardiogenic shock
    Device Description
    Automatic External Counterpulsation Device
    Ask a Question

    Page 1 of 1