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

    DIGITRACE HOME VIDEO SYSTEM

    K Number: K955787 · Decision Feb 9, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    40
    Applicant Total
    3
    Review Days
    50

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    Basic Information

    Device Name
    DIGITRACE HOME VIDEO SYSTEM
    K Number
    K955787
    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 Instruments, Inc.
    Date Received
    December 21, 1995
    Decision Date
    February 9, 1996
    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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    Other Clearances by New England Medical Instruments, Inc.

    K Number Device Name
    K910771 DIGITRACE(TM) HOME MONIT COMP/ELB(TM) EEG LUNCH BX
    K910279 MCSEER/MICRO CONTROLLER SLD ST EEG EVENT RECORDER