BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Fetal, Acoustic

    PMA: P870025 · Supplement: S005 · Decision Jul 17, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Stimulator, Fetal, Acoustic
    Trade Name
    COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR
    PMA Number
    P870025
    Supplement Number
    S005
    Device Class
    FDA Class 3
    Product Code
    MCP
    Generic Name
    Stimulator, fetal, acoustic
    Medical Specialty
    Unknown
    Advisory Committee
    Obstetrics/Gynecology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 17, 1996
    Date Received
    February 8, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A LABELING CHANGE TO PERMIT INTERFACE OF THE COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR WITH THE COROMETRICS MODEL 155 FETAL MONITOR

    Classifications

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

    Product Code Device Name
    MCP Stimulator, Fetal, Acoustic