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510(k) Data Aggregation

    K Number
    K013281

    Validate with FDA (Live)

    Device Name
    VERSALAB APM
    Manufacturer
    NICOLET BIOMEDICAL
    Date Cleared
    2002-04-18

    (198 days)

    Product Code
    HGM
    Regulation Number
    884.2740
    Type
    Abbreviated
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The VersaLab APM, antepartum monitor is a Perinatal Monitoring system for non-invasively measuring and graphically showing both maternal abdominal contractions and the fetal heart rate by means of display on a non-permanent graphical display as well as a permanent record on a thermal strip chart printer. This data is intended to aid in assessing the well being of the fetus during the final trimester of pregnancy [Non-Stress Test].

    Device Description

    Perinatal Monitoring system for non-invasively measuring and graphically showing both maternal abdominal contractions and the fetal heart rate by means of display on a non-permanent graphical display as well as a permanent record on a thermal strip chart printer.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, a study that proves the device meets acceptance criteria, sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth used, or how ground truth for training sets was established.

    The document is a 510(k) premarket notification letter from the FDA regarding the VersaLab APM device. It primarily discusses the substantial equivalence determination and the device's indications for use. It does not contain technical performance data or study details.

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