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

    HEMEDEX CRANIAL BOLT MODELS, 3601, 3602

    K Number: K032337 · Decision Oct 21, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    66
    Same Product Code
    104
    Applicant Total
    4
    Review Days
    84

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    Basic Information

    Device Name
    HEMEDEX CRANIAL BOLT MODELS, 3601, 3602
    K Number
    K032337
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1620
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hemedex Incorporated
    Date Received
    July 29, 2003
    Decision Date
    October 21, 2003
    Product Code
    GWM
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GWM Device, Monitoring, Intracranial Pressure

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    Other Clearances by Hemedex Incorporated

    K Number Device Name
    K141869 QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT
    K032127 HEMEDEX FIXATION DEVICE
    K013376 QFLOW 500 PERFUSION MONITORING SYSTEM