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

    THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK

    K Number: K081670 · Decision Oct 9, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    5
    Review Days
    118

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    Basic Information

    Device Name
    THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK
    K Number
    K081670
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardinal Health 207, Inc.
    Date Received
    June 13, 2008
    Decision Date
    October 9, 2008
    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 Cardinal Health 207, Inc.

    K Number Device Name
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    K092484 HELIOX LOW FLOW SENTRY BLENDER
    K093124 PURESOM NASAL MASK-SMALL, PURESOM NASAL MASK-MEDIUM, PURESOM NASAL MASK-LARGE, MODELS 11924-01, 11924-02, 11924-03
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