BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V

    K Number: K033657 · Decision Dec 19, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    33
    Applicant Total
    2
    Review Days
    28

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    Basic Information

    Device Name
    MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V
    K Number
    K033657
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.5225
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Living Data Technologies Corporation
    Date Received
    November 21, 2003
    Decision Date
    December 19, 2003
    Product Code
    DRN
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DRN Device, Counter-Pulsating, External

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