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

    MODIFICATION TO: EFLOW ELECTRONIC INHALER/NEBULIZER

    K Number: K072670 · Decision Dec 13, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    507
    Applicant Total
    10
    Review Days
    83

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    Basic Information

    Device Name
    MODIFICATION TO: EFLOW ELECTRONIC INHALER/NEBULIZER
    K Number
    K072670
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pari Innovative Manufacturers, Inc.
    Date Received
    September 21, 2007
    Decision Date
    December 13, 2007
    Product Code
    CAF
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    Y

    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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