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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
    Type
    Special
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is intended to be used with positive airway pressure devices operating at or above 4cmH 2 O for the treatment of adult obstructive sleep apnea.

    Device Description

    iMask TM Nasal CPAP Mask

    AI/ML Overview

    This document is a 510(k) clearance letter for a medical device called the "iMask Nasal CPAP Mask". It does not contain information about acceptance criteria or a study proving that the device meets such criteria.

    Therefore, I cannot provide the requested information. The document focuses on the regulatory clearance process and confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It does not detail specific performance testing results or study methodologies.

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