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510(k) Data Aggregation

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

    (181 days)

    Product Code
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Accurate Meditech Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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<40. The Accurate Mini Non-invasive BPM is intended for spot-checking of adult patients in hospitals, clinics. long-term care, and home use. The measurement results are stored locally in the device. The Accurate Mini Non-invasive BPM measures blood pressure based on Pulse Wave Transit Time (PWTT) obtained Local Pulse Wave Velocity (PWV) from dual Piezo Sensors and radial artery parameters from Near InfraRed Spectroscopy (NIRS) Optic sensor.
    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.
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    K Number
    K222658
    Device Name
    Accurate 24 Non-invasive blood pressure monitor
    Date Cleared
    2023-06-21

    (292 days)

    Product Code
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Accurate Meditech Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is a wrist-worn digital monitor intended for use in measuring blood pressure and pulse rate in adult patient (age 20-70) population with wrist circumference ranging from 13.5 cm to 21.5 cm and BMI<40. The Accurate 24 Non-invasive BPM is intended for spot-checking of adult patients in hospitals, clinics, long-term care, and home use and able to obtain results. The measurement results store in the device locally. The Accurate 24 Non-invasive BPM measures blood pressure based on Pulse Wave Transit Time (PWTT) obtained Local Pulse Wave Velocity (PWV) from dual Piezo Sensors and radial artery parameters from NIRS Optic sensors.
    Device Description
    Accurate 24 Non-Invasive blood pressure monitor device is a small, lightweight, handheld device intended to measure and display blood pressure trending (Systolic and Diastolic) and spot-check of pulse rate. Measurement is performed on the wrist of 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.
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    Ask a specific question about this device

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