BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Analyzer, Data, Obstetric

    PMA: P020001 · Supplement: S009 · Decision Nov 18, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Analyzer, Data, Obstetric
    Trade Name
    STAN S31 FETAL HEART MONITOR
    PMA Number
    P020001
    Supplement Number
    S009
    Device Class
    FDA Class 3
    Product Code
    HEO
    Generic Name
    Analyzer, data, obstetric
    Regulation Number
    884.2050
    Medical Specialty
    Obstetrics/Gynecology
    Advisory Committee
    Obstetrics/Gynecology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 18, 2011
    Date Received
    September 21, 2011
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF AN ACCESSORY, THE STAN VIEWER LIVE, WHICH ALLOWS REMOTE VIEWING OF AN ONGOING STAN S31 RECORDING.

    Classifications

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

    Product Code Device Name
    HEO Analyzer, Data, Obstetric