BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MEUROMETRICS MONITOR

    K Number: K803233 · Decision Jan 12, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    14
    Applicant Total
    1
    Review Days
    21

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    Basic Information

    Device Name
    MEUROMETRICS MONITOR
    K Number
    K803233
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    882.1420
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Dade Medical, Inc.
    Date Received
    December 22, 1980
    Decision Date
    January 12, 1981
    Product Code
    GWS
    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
    GWS Analyzer, Spectrum, Electroencephalogram Signal

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