BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

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

    PMA: P890063 · Supplement: S003 · Decision Jan 31, 1994
    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 SYSTEM & TERM GUARD I & TERM GUARD II SYS.
    PMA Number
    P890063
    Supplement Number
    S003
    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
    January 31, 1994
    Date Received
    June 11, 1991
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    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)