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510(k) Data Aggregation

    K Number
    K021225
    Device Name
    ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR, MODEL CARDIOCARE 1000I
    Manufacturer
    ROSSMAX INTERNATIONAL LTD.
    Date Cleared
    2002-05-22

    (34 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR, MODEL CARDIOCARE 1000I

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

    The blood pressure monitor is used to measure systolic, diastolic, and pulse rates in adult consumers with arm circumference between 22 cm to 32 cm (8.7" to 12.6")

    Device Description

    Rossmax Automatic Blood Pressure Monitor, model CardioCare 1000i

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a blood pressure monitor. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

    Therefore, I cannot fulfill the request using only the provided text. The document confirms that the device, Rossmax Automatic Blood Pressure Monitor, Model CardioCare 1000i, is substantially equivalent to legally marketed predicate devices for measuring systolic, diastolic, and pulse rates in adults with a specific arm circumference. However, it does not detail the technical studies or their results that would underpin this equivalence.

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