BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Oximeter, Fetal Pulse

    PMA: P990053 · Decision May 12, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Oximeter, Fetal Pulse
    Trade Name
    OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM
    PMA Number
    P990053
    Device Class
    FDA Class 3
    Product Code
    MMA
    Generic Name
    Oximeter, fetal pulse
    Medical Specialty
    Unknown
    Advisory Committee
    Obstetrics/Gynecology
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    May 12, 2000
    Date Received
    September 21, 1999
    Expedited Review
    N
    Docket Number
    00M-1448

    Advisory Committee Statement

    APPROVAL FOR THE NELLCOR N-400 FETAL OXYGEN SATURATION MONITORING SYSTEM (OXIFIRST(TM) SYSTEM).

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MMA Oximeter, Fetal Pulse