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510(k) Data Aggregation

    K Number
    K093013
    Date Cleared
    2010-01-08

    (101 days)

    Product Code
    Regulation Number
    870.1130
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    BLOOD PRESSURE MONITOR, MODEL MD200A

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

    MD200A Blood Pressure Monitor is an automatic electronic blood pressure monitor intended to measure the systolic, diastolic and mean blood pressure as well as pulse rate via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used on adult, pediatric and neonatal individuals.

    Device Description

    MD200A Blood Pressure Monitor is a handheld device, which can connected to the blood pressure cuff with various specifications, intended for measuring the systolic, diastolic and mean blood pressure as well as pulse rate via non-invasive oscillometric technique.

    AI/ML Overview

    The provided text details the 510(k) summary for the MD200A Blood Pressure Monitor (K093013). However, it does not contain the specific information requested in the prompt regarding acceptance criteria, reported device performance, details of a study with sample sizes, expert involvement, adjudication methods, or ground truth establishment.

    The document states: "Performance testing including clinical and bench testing was conducted to validate and verify that the proposed device, MD200A Blood Pressure Monitor met all design specifications and was substantially equivalent to the predicate device." While a clinical study is alluded to, its specifics are not provided in this summary.

    Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or delve into the details of the study, as this information is absent from the provided text.

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