BEUDAMED
    Product Code: PMB FDA class 2 21 CFR 868.5105

    External Airway

    Anesthesiology

    The External Airway (product code PMB) is a Class 2 anesthesiology device intended to maintain airway patency using negative pressure during mild to moderate sedation, regulated under 868.5105. It requires 510(k) clearance and falls within the anesthesiology medical specialty. The device is not an implant and is not life-sustaining.

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

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    Basic Information

    Product Code
    PMB
    Device Class
    FDA class 2
    Regulation Number
    868.5105
    Medical Specialty
    Anesthesiology
    Review Panel
    AN
    Submission Type
    1

    Device Characteristics

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

    Definition

    This device is intended to maintain airway patency using negative pressure during mild to moderate sedation.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    DEN140024 cNEP Airway