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510(k) Data Aggregation

    K Number
    K121266
    Device Name
    CARDIOSCOPE
    Manufacturer
    PULSECOR LIMITED
    Date Cleared
    2012-12-11

    (229 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K070060,K101002,K012487,K110603
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    CardioScope™ is a non-invasive, compact standalone measurement device that automatically measures systolic and diastolic pressure, and pulse rate in adult and pediatric patients. CardioScope also provides non-invasive central (aortic) systolic, mean and diastolic blood pressure, and pulse waveform intended for use in adult patients.

    CardioScope performs measurements using a conventional oscillometric method via a brachial cuff on the upper arm.

    The device is intended to be used under supervision by qualified healthcare personnel.

    Caution: Federal (USA) law restricts this device to sale by or on order of a physician.

    Device Description

    The CardioScope™ is a compact standalone measurement device that incorporates a SP10 compliant conventional oscillometric blood pressure module using a brachial cuff on the upper arm.

    The CardioScope first measures brachial systolic and diastolic blood pressures and pulse rate using the Oscillometric method. It then inflates the cuff to a pressure about 30 mmHg higher than systolic (Suprasystolic) pressure to acquire a further oscillometric pulse waveform. The suprasystolic pulse waveform is used in combination with the conventional upper-arm blood pressures to derive central systolic, diastolic and mean blood pressures.

    AI/ML Overview

    Here's a breakdown of the requested information regarding the acceptance criteria and the study proving the CardioScope™ device meets them, based on the provided 510(k) summary:

    Acceptance Criteria and Device Performance Study

    1. Table of Acceptance Criteria and Reported Device Performance

    ParameterAcceptance Criteria (Target)Reported Device Performance
    Agreement with Tonometric Estimation (Central Systolic, Diastolic, Mean BP)Mean differences
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