BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent 🇺🇸 United States

    THERMAL DIFFUSION CEREBRAL BLOOD FLOW MONITOR

    K Number: K850657 · Decision Feb 22, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    25

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    Basic Information

    Device Name
    THERMAL DIFFUSION CEREBRAL BLOOD FLOW MONITOR
    K Number
    K850657
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Flowtronics, Inc.
    Date Received
    January 28, 1985
    Decision Date
    February 22, 1985
    Product Code
    LME
    Advisory Committee
    Unknown
    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
    LME Monitor, Blood-Flow, Cerebral, Thermal Diffusion