BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CLARISSA INFANT NCPAP CANNULA

    K Number: K032922 · Decision Sep 22, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    2
    Review Days
    366

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    Basic Information

    Device Name
    CLARISSA INFANT NCPAP CANNULA
    K Number
    K032922
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Airways Ltd., Inc.
    Date Received
    September 22, 2003
    Decision Date
    September 22, 2004
    Product Code
    CBK
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CBK Ventilator, Continuous, Facility Use

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    Other Clearances by Airways Ltd., Inc.

    K Number Device Name
    K951944 NASALFLAIR