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

    MODIFICATION TO BIO-LOGIC SLEEPSCAN

    K Number: K983913 · Decision Nov 25, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    63
    Applicant Total
    45
    Review Days
    21

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    Basic Information

    Device Name
    MODIFICATION TO BIO-LOGIC SLEEPSCAN
    K Number
    K983913
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bio-Logic Systems Corp.
    Date Received
    November 4, 1998
    Decision Date
    November 25, 1998
    Product Code
    OLV
    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
    OLV Standard Polysomnograph With Electroencephalograph

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