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510(k) Data Aggregation

    K Number
    K082630
    Device Name
    VITALCHECK BLOOD PRESSURE CUFF, MODEL ZVC4000 SERIES
    Manufacturer
    ZEFON INTL.
    Date Cleared
    2008-12-19

    (100 days)

    Product Code
    DXQ
    Regulation Number
    870.1120
    Type
    Abbreviated
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VITALCHECK BLOOD PRESSURE CUFF, MODEL ZVC4000 SERIES

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

    Zefon NIPB blood pressure cuffs, tubing & adapters are reusable accessories 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

    The provided text is a 510(k) premarket notification decision letter from the FDA to Zefon International regarding their VitalCheck Blood Pressure Cuff, NIBP Tubing, and Adapters.

    This document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory approval document stating that the FDA has reviewed the device and determined it is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot fulfill the request for information regarding acceptance criteria and a study from the provided text.

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