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510(k) Data Aggregation

    K Number
    K080366
    Device Name
    DURACHECK BLOOD PRESSURE CUFF, MODEL ZDC4000 SERIES
    Manufacturer
    ZEFON INTL.
    Date Cleared
    2008-06-09

    (118 days)

    Product Code
    DXQ,DXO
    Regulation Number
    870.1120
    Type
    Abbreviated
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Zefon blood pressure cuff is a reusable device to be used in conjunction with non-invasive automatic blood pressure monitors or non-invasive manual blood pressure measurement systems.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for the Zefon DuraCheck Blood Pressure Cuffs. It indicates that the device has been found substantially equivalent to a predicate device. However, it does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert evaluations.

    Therefore, based solely on the provided text, I cannot answer any of the questions regarding acceptance criteria, study details, and performance. The document focuses on regulatory clearance, not performance data.

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