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

    QFLOW 500 PERFUSION MONITORING SYSTEM

    K Number: K013376 · Decision May 8, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    136
    Applicant Total
    4
    Review Days
    209

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    Basic Information

    Device Name
    QFLOW 500 PERFUSION MONITORING SYSTEM
    K Number
    K013376
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2100
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hemedex Incorporated
    Date Received
    October 11, 2001
    Decision Date
    May 8, 2002
    Product Code
    DPW
    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
    DPW Flowmeter, Blood, Cardiovascular

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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
    K032337 HEMEDEX CRANIAL BOLT MODELS, 3601, 3602