BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Oximeter, Fetal Pulse

    PMA: P990053 · Supplement: S003 · Decision Nov 9, 2001
    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
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    MMA
    Generic Name
    Oximeter, fetal pulse
    Medical Specialty
    Unknown
    Advisory Committee
    Obstetrics/Gynecology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    November 9, 2001
    Date Received
    October 12, 2001
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE IN THE STERILIZATION PROCESS BY ELIMINATING THE POST STERILIZATION VISUAL INSPECTION FOR THE OXYFIRST FETAL SENSOR FS14-SERIES. ALSO, A CHANGE IN THE SITE OF FINAL PRODUCT DISTRIBUTION FROM THE PRESENT FACILITY IN CARLSBAD, CALIFORNIA TO A TYCO DISTRIBUTION FACILITY IN ATLANTA, GEORGIA.

    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