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

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

    PMA: P890063 · Decision Sep 12, 1990
    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(R) HOME UTERINE ACTIVITY MONITORING SYSTEM
    PMA Number
    P890063
    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 (Reclassification)
    Decision Code
    APRL
    Decision Date
    September 12, 1990
    Date Received
    November 15, 1989
    Expedited Review
    N
    Docket Number
    90M-0315

    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)