BEUDAMED
    Product Code: FNC FDA class 2 21 CFR 868.5710

    Tent, Pediatric Aerosol

    Anesthesiology

    The Pediatric Aerosol Tent is a device that encloses a pediatric patient in a mist-filled environment to deliver humidified air or oxygen therapy, commonly used in the treatment of croup and respiratory conditions in children. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FNC, regulated under 21 CFR 868.5710 in the Anesthesiology specialty.

    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
    FNC
    Device Class
    FDA class 2
    Regulation Number
    868.5710
    Medical Specialty
    Anesthesiology
    Review Panel
    AN
    Submission Type
    1

    Device Characteristics

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

    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
    K884922 THE BREATHE EASE NURSERY VAPOR TENT