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510(k) Data Aggregation

    K Number
    K050826
    Device Name
    FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS
    Manufacturer
    Date Cleared
    2006-04-10

    (374 days)

    Product Code
    Regulation Number
    884.2740
    Why did this record match?
    Applicant Name (Manufacturer) :

    CETRO AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    These devices are replacement accessories for the original manufacturer's fetal monitor transducers and are intended to monitor and chart Fetal Heart Rate and maternal uterine activity. These devices are replacement accessories for the original manufacturer's fetal monitor transducers and are intended to obtain signals to monitor and chart Fetal Heart Rate and maternal uterine activity on a fetal monitor.
    Device Description
    Cetro America, Inc. Transducers for Ultrasonic and Tocodynamometer fetal monitoring will be used as replacements for similar transducers manufactured by Corometrics (currently GE), Hewlett Packard Medical (currently Phillips Medical) and Advanced Medical Systems (currently Spacelabs Medical) and their respective fetal monitors. The ultrasound transducer is used to detect Fetal Heart Rate (FHR) using the ultrasound Doppler shift technology. Ultrasound transducers operate in a pulsed Doppler mode with around a 33% Duty Cycle. The Tocodynamometer transducer uses a strain gauge to detect uterine contraction frequency and duration during labor.
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