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

    HIOX80 AEROSOL ADAPTER

    K Number: K032516 · Decision Mar 4, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    507
    Applicant Total
    26
    Review Days
    203

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    Basic Information

    Device Name
    HIOX80 AEROSOL ADAPTER
    K Number
    K032516
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sensor Medics Corp.
    Date Received
    August 14, 2003
    Decision Date
    March 4, 2004
    Product Code
    CAF
    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
    CAF Nebulizer (Direct Patient Interface)

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    K991972 INFANT FLOW SYSTEM
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