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    K Number
    K040392
    Device Name
    TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING
    Manufacturer
    AMERICAN I.V. PRODUCTS, INC.
    Date Cleared
    2004-09-14

    (210 days)

    Product Code
    HFM
    Regulation Number
    884.2720
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K982651,K992811
    Why did this record match?
    Device Name :

    TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    These devices are intended to be used as replacement accessories to Corometrics and Hewlett Packard Monitors, to measure fetal heart rate and uterine contractions in the gravid patient.

    AIV Transducer Model Numbers: FM10835 and FM10836. These devices are a direct replacement for the EPIC EFU200-20, Ultrasound Transducer for measuring fetal heart rate.

    AIV Transducer Model Numbers: FM10839 and FM10840. These devices are a direct replacement for the Corometric's 2264LAX. TOCO Transducer for measuring uterine contractions.

    AIV Transducer Model Number: FM10841. This device is a direct replacement for the EPIC EFT200-20, TOCO Transducer for measuring uterine contractions.

    Device Description

    AIV's ultrasound (US) and tocodynamometer (TOCO) transducers are replacements for similar transducers manufactured by Corometrics and Hewlett Packard for their respective monitors. The AIV transducers are also a replacement for similar transducers manufactured by Epic for use on Corometrics and Hewlett Packard monitors.

    The US transducers are used to detect the fetal heart rate using Doppler shift technology. The TOCO transducers detect uterine activity using a strain gauge for evaluating contractions. These transducers are intended to be a direct replacement for the Corometrics, Hewlett Packard and Epic transducers.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the fetal monitoring transducers, formatted as requested:

    Acceptance Criteria and Device Performance

    Acceptance CriteriaReported Device Performance
    Acoustic Output
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    K Number
    K992811
    Device Name
    TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING
    Manufacturer
    EPIC MEDICAL EQUIPMENT SERVICES, INC.
    Date Cleared
    2000-01-18

    (151 days)

    Product Code
    HFM
    Regulation Number
    884.2720
    Type
    Abbreviated
    Panel
    Radiology
    Reference & Predicate Devices
    K843385,K891595,K934959,K964770,K900480
    Why did this record match?
    Device Name :

    TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    These devices are intended for use as replacement accessories to Corometrics and Hewlett Packard Monitors, to measure fetal heart rate and uterine contractions in the gravid patient.

    Device Description

    Epic's ultrasound and tocodynamometer (toco) transducers are replacements for similar transducers manufactured by Corometrics and Hewlett Packard for their respective monitors. The ultrasound transducers are used to detect the fetal heart rate using Doppler shift technology and the toco transducers detect uterine activity using a strain gauge for evaluating the fetal heart rate during a contraction. These transducers are intended to be a direct replacement for the OEM transducers.

    AI/ML Overview

    Here's a summary of the acceptance criteria and the study information based on the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Intended Use (Measure fetal heart rate and uterine contractions in the gravid patient.)Same as predicate devices. The Epic transducers are replacements for Corometrics and Hewlett Packard transducers and are intended to measure fetal heart rate and uterine contractions.
    Anatomical Sites (Ultrasound transducer on maternal abdomen aimed at fetal heart; toco transducer on maternal abdomen over fundal area of uterus.)Same as predicate devices. The Epic transducers are replacements for Corometrics and Hewlett Packard transducers and are intended for the same anatomical placement.
    Target Patient Population (Gravid patients, especially during labor.)Same as predicate devices. The Epic transducers are replacements for Corometrics and Hewlett Packard transducers and are intended for the same patient population.
    FHR Range (Dependent upon monitor specifications.)Same as predicate devices. The Epic transducers are replacements for Corometrics and Hewlett Packard transducers and are dependent on the connected monitor for FHR range.
    Uterine Activity Range (Dependent upon monitor specifications.)Same as predicate devices. The Epic transducers are replacements for Corometrics and Hewlett Packard transducers and are dependent on the connected monitor for uterine activity range.
    Patient Use/Reuse (Reusable.)Same as predicate devices. The Epic transducers are replacements for Corometrics and Hewlett Packard transducers and are reusable.
    Sterility (Non-Sterile.)Same as predicate devices. The Epic transducers are replacements for Corometrics and Hewlett Packard transducers and are non-sterile.
    Description of Patient Attachment (Attach to patient with elastic straps around the mother.)Same as predicate devices. The Epic transducers are replacements for Corometrics and Hewlett Packard transducers and attach with elastic straps.
    Cable Length (8 feet.)Same as predicate devices (8 feet).
    Acoustic Output**
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