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510(k) Data Aggregation

    K Number
    K242352
    Device Name
    Accurate Mini Non-invasive blood pressure monitor (AMB-001)
    Manufacturer
    Accurate Meditech Inc.
    Date Cleared
    2025-02-05

    (181 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K222658
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device is a wrist-worn digital monitor intended for use in measuring blood pressure and pulse rate in adult patients of ages 20 -70 with wrist circumference from 13.5 cm to 21.5 cm and BMI

    Device Description

    Accurate Mini Non-Invasive blood pressure monitor device is a small, lightweight, handheld device intended to measure and display blood pressure trending (Systolic and Diastolic) and spotcheck of pulse rate. Measurement is performed on the wrist at the radial artery. This blood pressure monitor uses the pulse wave transit time with the hemodynamic method to measure the systolic and diastolic blood pressure and pulse rate. This device serves to measure the systolic and diastolic blood pressure and pulse rate of adults in a non-invasive manner.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

    Device: Accurate Mini Non-invasive blood pressure monitor (AMB-001)

    1. Table of Acceptance Criteria and Reported Device Performance

    CharacteristicAcceptance Criteria (ISO 81060-2:2018)Reported Device Performance (Achieved)Pass/Fail
    Blood PressureSBPDBP
    Mean Bias (mmHg)
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