BEUDAMED
    FDA PMA FDA Class 2 Approved (Reclassification) 🇺🇸 United States

    Home Uterine Activity Monitor

    PMA: P910063 · Decision Sep 29, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Home Uterine Activity Monitor
    Trade Name
    CAREFONE(TM)HOME UTERINE ACTIVITY MONITOR SYSTEM
    PMA Number
    P910063
    Device Class
    FDA Class 2
    Product Code
    LQK
    Generic Name
    Home uterine activity monitor
    Regulation Number
    884.2730
    Medical Specialty
    Obstetrics/Gynecology
    Advisory Committee
    Obstetrics/Gynecology
    Decision
    Approved (Reclassification)
    Decision Code
    APRL
    Decision Date
    September 29, 1995
    Date Received
    October 21, 1991
    Expedited Review
    N
    Docket Number
    96M-0255

    Advisory Committee Statement

    APPROVAL FOR CAREFONE HOME UTERINE ACTIVITY MONITORING SYSTE, MODEL 2001

    Classifications

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

    Product Code Device Name
    LQK Home Uterine Activity Monitor