BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Oximeter, Fetal Pulse

    PMA: P990053 · Supplement: S009 · Decision Nov 25, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Oximeter, Fetal Pulse
    Trade Name
    OXI FIRST FETAL OXYGEN SATURATION MONITORING SYSTEM
    PMA Number
    P990053
    Supplement Number
    S009
    Device Class
    FDA Class 3
    Product Code
    MMA
    Generic Name
    Oximeter, fetal pulse
    Medical Specialty
    Unknown
    Advisory Committee
    Obstetrics/Gynecology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 25, 2002
    Date Received
    April 17, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A NEW MANUFACTURING FACILITY LOCATED AT NELLCOR PURITAN BENNETT, INC., MINNEAPOLIS, MINNESOTA. THIS FACILITY WILL PERFORM MANUFACTURING OF THE FSP02-PM FETAL PATIENT MODULES.

    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