BEUDAMED
    Product Code: QKS FDA not classified

    Inhaler, Metered Dose Or Dry Powder, Cder Or Cber Led

    Unknown

    The Inhaler, Metered Dose Or Dry Powder (CDER or CBER Led) is a not-classified drug-device combination product consisting of metered dose or dry powder inhalers that deliver drug substances to the site of action through the inhalation route. It is unclassified because the primary mode of action is attributed to the drug component regulated by CDER or CBER, reviewed by the Anesthesiology panel. The product code is QKS, with no regulation number assigned. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    QKS
    Device Class
    FDA not classified
    Medical Specialty
    Unknown
    Review Panel
    AN
    Submission Type
    3

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Metered Dose Inhaler and Dry Powder Inhalers are products that deliver drug substance to the site of action through the inhalation route

    Unclassified Reason

    4

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.