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

    DIGITRACE SLEEP COMPUTER, SLEEPPAC, HOME SLEEP SYSTEM

    K Number: K944833 · Decision May 4, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    40
    Applicant Total
    1
    Review Days
    216

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    Basic Information

    Device Name
    DIGITRACE SLEEP COMPUTER, SLEEPPAC, HOME SLEEP SYSTEM
    K Number
    K944833
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    New England Medical Monitoring Co.
    Date Received
    September 30, 1994
    Decision Date
    May 4, 1995
    Product Code
    OMB
    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
    OMB Automatic Event Detection Software For Full-Montage Electroencephalograph

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