BEUDAMED
    Product Code: RAO FDA not classified

    Intrusion Alarm/Security

    Unknown

    The intrusion alarm/security classification (product code RAO) covers equipment using ultrasound to provide security and intrusion alarm functionality in commercial or 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
    RAO
    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 provide security and an intrusion alarm in a commercial or household application