BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Oximeter, Fetal Pulse

    PMA: P000016 · Supplement: S001 · Decision Nov 9, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Oximeter, Fetal Pulse
    Trade Name
    COROMETRICS MODEL 120 SERIES MATERNAL/FETAL MONITOR W/INTEGRATED FETAL PULSE OXIMETRY
    PMA Number
    P000016
    Supplement Number
    S001
    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 9, 2001
    Date Received
    May 21, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MANUFACTURING FACILITY LOCATED AT WIPRO GE MEDICAL SYSTEMS, BANGALORE, INDIA.

    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