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510(k) Data Aggregation

    K Number
    K051559
    Device Name
    IMASK, MODELS 100, 200 AND 300
    Manufacturer
    VITAL SIGNS COLORADO, INC.
    Date Cleared
    2005-07-08

    (25 days)

    Product Code
    BZD
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    VITAL SIGNS COLORADO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is intended to be used with positive airway pressure devices operating at or above 4cmH <sub>2</sub> O for the treatment of adult obstructive sleep apnea.
    Device Description
    iMask <sup>TM</sup> Nasal CPAP Mask
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