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

    NEBULIZER (DIRECT PATIENT INTERFACE)

    K Number: K915075 · Decision Jul 16, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    507
    Applicant Total
    9
    Review Days
    251

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    Basic Information

    Device Name
    NEBULIZER (DIRECT PATIENT INTERFACE)
    K Number
    K915075
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medi Nuclear Corp., Inc.
    Date Received
    November 8, 1991
    Decision Date
    July 16, 1992
    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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