BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Monitor, Uterine Contraction, External (For Use In Clinic)

    PMA: P890063 · Supplement: S004 · Decision Jun 16, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12

    Basic Information

    Device Name
    Monitor, Uterine Contraction, External (For Use In Clinic)
    Trade Name
    GENESIS HOME UTERINE ACTIVITY MONITORING SYSTEM (HUAM)
    PMA Number
    P890063
    Supplement Number
    S004
    Device Class
    FDA Class 2
    Product Code
    HFM
    Generic Name
    Monitor, uterine contraction, external (for use in clinic)
    Regulation Number
    884.2720
    Medical Specialty
    Obstetrics/Gynecology
    Advisory Committee
    Obstetrics/Gynecology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 16, 1995
    Date Received
    April 7, 1993
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Classifications

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

    Product Code Device Name
    HFM Monitor, Uterine Contraction, External (For Use In Clinic)