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

    BREEZE DIGITAL INFLATION DEVICE

    K Number: K953676 · Decision Mar 29, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    56
    Applicant Total
    8
    Review Days
    235

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    Basic Information

    Device Name
    BREEZE DIGITAL INFLATION DEVICE
    K Number
    K953676
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Namic
    Date Received
    August 7, 1995
    Decision Date
    March 29, 1996
    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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    Other Clearances by Namic

    K Number Device Name
    K951722 PERCEPTOR COMPENSATOR MORSE MANIFOLD
    K921322 MORSE ANESTHESIA MANIFOLD
    K822100 HIGH PRESSURE CONTRAST INJECTION LINE
    K813549 CONTINUOUS FLUSH DEVICE
    K790083 CATHETER, ARTERIAL LINE
    K790082 ARTERIAL EXTENSION SET
    K782095 STOPCOCKS, MANIFOLDS