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510(k) Data Aggregation

    K Number
    K102704
    Device Name
    EASY CUFF
    Manufacturer
    JOAN SPIEGEL, MD
    Date Cleared
    2011-03-10

    (171 days)

    Product Code
    BSK
    Regulation Number
    868.5750
    Why did this record match?
    Applicant Name (Manufacturer) :

    JOAN SPIEGEL, MD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To inflate cuffs and to measure and monitor intra-cuff pressures of endotracheal, supraglottic airways, or tracheostomy tubes.
    Device Description
    The Easy Cuff™ is simple in-line pressures monitor which contains a calibrated diaphragm which distends with increases in cuff pressure. It is also capable of inflating or deflating the cuff.
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