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

    SCIMED ENCORE INFLATION DEVICE, MODEL SM2500

    K Number: K903503 · Decision Oct 9, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    56
    Applicant Total
    8
    Review Days
    67

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    Basic Information

    Device Name
    SCIMED ENCORE INFLATION DEVICE, MODEL SM2500
    K Number
    K903503
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Scimed
    Date Received
    August 3, 1990
    Decision Date
    October 9, 1990
    Product Code
    MAV
    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
    MAV Syringe, Balloon Inflation

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