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

    MODEL 515 NEO-TRAK NEONATAL MONITOR

    K Number: K823904 · Decision May 25, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    338
    Applicant Total
    136
    Review Days
    148

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    Basic Information

    Device Name
    MODEL 515 NEO-TRAK NEONATAL MONITOR
    K Number
    K823904
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Ge Medical Systems Information Technologies
    Date Received
    December 28, 1982
    Decision Date
    May 25, 1983
    Product Code
    DRT
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

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