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510(k) Data Aggregation

    K Number
    K230769
    Device Name
    PrevisEA Device
    Manufacturer
    Entac Medical Inc.
    Date Cleared
    2023-05-19

    (60 days)

    Product Code
    DQD
    Regulation Number
    870.1875
    Why did this record match?
    Applicant Name (Manufacturer) :

    Entac Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PrevisEA is a compact, non-invasive device placed on the abdomen to capture the digestive sounds of patients. PrevisEA displays information which assists physicians in assessing the digestive health of patients. This device is for prescription use only and should be used under the direction of a licensed healthcare practitioner. The PrevisEA device has not been tested for and it is not intended for pediatric use.
    Device Description
    PrevisEA is a non-invasive, self-contained, medical device with a proprietary algorithm used to assess the digestive health of patients. The device includes a stethoscope diaphragm, sound chamber, embedded microphone and CPU, as well as a display screen and buttons. The PrevisEA device is a convenient, single-use, disposable unit, which attaches to the abdomen of the patient via an adhesive wafer on the back of the device. The PrevisEA is a single-use, disposable unit, which avoids the need for cleaning and disinfection. The PrevisEA requires no cable connections for operation of the device. Integration of the above components allow auscultation and digital capture of digestive sounds, such as MH4. Messages are transmitted to the easy-to-read display screen on the front of the device. The PrevisEA detects the acoustic biomarker MH4 and quantifies the number of MH4 detections over a 4-minute interval, which it compares to a predefined threshold to determine the presence of abnormal digestive health in patients following major abdominal surgery, such as gastrointestinal impairment (GII).
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    K Number
    K211068
    Device Name
    PrevisEA Device
    Manufacturer
    Entac Medical Inc.
    Date Cleared
    2021-08-04

    (114 days)

    Product Code
    DQD, DOD
    Regulation Number
    870.1875
    Why did this record match?
    Applicant Name (Manufacturer) :

    Entac Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PrevisEA is a compact, non-invasive device placed on the abdomen to capture the digestive sounds of patients. PrevisEA displays information which assists physicians in assessing the digestive health of patients. This device is for prescription use only and should be used under the direction of a licensed healthcare practitioner. The PrevisEA device has not been tested for and it is not intended for pediatric use.
    Device Description
    PrevisEA is a non-invasive, self-contained, medical device with a proprietary algorithm used to assess the digestive health of patients. The device includes a stethoscope diaphragm, sound chamber, embedded microphone and CPU, as well as a display screen and buttons. The PrevisEA device is a convenient, single-use, disposable unit, which attaches to the abdomen of the patient via an adhesive wafer on the back of the device. The PrevisEA is a single-use, disposable unit, which avoids the need for cleaning and disinfection. The PrevisEA requires no cable connections for operation of the device. Integration of the above components allow auscultation and digital capture of digestive sounds, such as MH4. Messages are transmitted to the easy-to-read display screen on the front of the device. The PrevisEA detects the acoustic biomarker MH4 and quantifies the number of MH4 detections over a 4-minute interval, which it compares to a predefined threshold to determine the presence of abnormal digestive health in patients following intestinal surgery, such as gastrointestinal impairment (GII).
    Ask a Question

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