BEUDAMED
    Product Code: RAM FDA not classified

    Humidifier

    Unknown

    The humidifier classification (product code RAM) covers equipment using ultrasound to disperse water droplets into an area in household applications, with no medical purpose. These devices are not classified within the standard medical device framework and are GMP-exempt. No regulation number, medical specialty, or submission type is assigned.

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

    Basic Information

    Product Code
    RAM
    Device Class
    FDA not classified
    Medical Specialty
    Unknown

    Device Characteristics

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

    Definition

    Equipment using ultrasound to disperse water droplets into an area in a household application