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510(k) Data Aggregation

    K Number
    K954847
    Device Name
    DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIES
    Manufacturer
    OCG SYSTEMS, INC.
    Date Cleared
    1996-05-22

    (212 days)

    Product Code
    HFM
    Regulation Number
    884.2720
    Why did this record match?
    Applicant Name (Manufacturer) :

    OCG SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disco™ Uterine Contraction Transducer System is designed and intended for use in monitoring the progress of labor by measuring the duration, frequency and relative pressure of uterine contractions with a transducer strapped to the maternal abdomen.
    Device Description
    The Disco™ Uterine Contraction Transducer System is a non-sterile, single patient use external uterine contraction transducer and accessories. The system consists of a disposable belt with the transducer, an adapter cable with sensitivity switch for use with either Corometrics or Hewlett Packard patient monitor, and the package with appropriate label copy. The Disco™ Uterine Contraction Transducer System uses a transducer that is placed in contact with the maternal abdomen and the output signal is displayed on a monitor and/or recording device. The transducer is composed of a mylar sheet with a pressure sensitive ink silk screened to its surface. This ink responds to changes in pressure from the foam pad by changing its electrical resistance. A series of conductive silver traces silk screened to a rigid ceramic substrate allow termination and measurement of this changing electrical resistance. A firm, yet flexible rounded elastomeric button is used to transfer the uterine contraction from the patient to the transducer. It is mounted in the center of the transducer and has an achesive bond to the foam pad at its base. A thin, flexible, stranded, insulated wire is used to connect the transducer to the adapter cable. A two wire RJ-11 male telephone type connector is used as the electrical interface for the transducer. Because the pressure sensitive ink produces a stronger signal than strain gauge type transducers, the Disco™ Uterine Contraction Transducer System has an output control switch to adjust the level of the output signal.
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