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    K Number
    K133125
    Device Name
    WITHINGS BLOOD PRESURE MONITOR
    Manufacturer
    WITHINGS
    Date Cleared
    2014-03-24

    (175 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K051539,K110872,K120672
    Why did this record match?
    Device Name :

    WITHINGS BLOOD PRESURE MONITOR

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

    The Withings Blood Pressure Monitor, Upper Arm Type: BP-801 is noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to be 9 to 17 inches (22cm-42cm) for Upper Arm type.

    Device Description

    The Withings BP-801 is a blood pressure monitor intended for use in measuring blood pressure and pulse rate in adult patient population with arm circumference ranging from 9 to 17 inches (22 - 42 cm) via an arm cuff. It is designed and manufactured according to IEC 80601-2-30, Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers. The operational principle is based on oscillometric and silicon integrates pressure sensor technology it can calculate the systolic and diastolic blood pressure, the measurement results can also be classified by the function of blood pressure classification indicator. The Withings BP-801 is a blood pressure monitor achieves its function by integrate the device with an iPhone 4S. As it does not include a LCD or other display components, it is necessary for the new device to connect to an iPhone 4S containing a support software to constitute a complete blood pressure measurement system. And the new device connects iPhone 4S through Bluetooth or USB cable.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study details for the Withings Blood Pressure Monitor BP-801, based on the provided text:

    1. Acceptance Criteria and Reported Device Performance

    The device's performance was evaluated against the ANSI/AAMI/ISO 81060-1:2007 & ANSI/AAMI/ISO 81060-2:2009 & ANSI/AAMI/IEC 80601-2-30:2009 protocols.

    Acceptance CriteriaDevice Performance - SystolicDevice Performance - Diastolic
    Criterion 1: The mean error of determination for 108 individual paired determinations shall not be greater than 5.0 mmHg, with a standard deviation no greater than 8.0 mmHg.Mean Difference: -0.242 mmHg
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