BEUDAMED
    Product Code: NAS FDA class 2 21 CFR 874.1090

    Tympanometer

    Ear, Nose, Throat

    The Tympanometer is an ENT diagnostic device used to measure the compliance (mobility) of the tympanic membrane (eardrum) and middle ear system by varying air pressure in the ear canal. It is used to diagnose middle ear disorders such as otitis media with effusion, tympanic membrane perforations, and ossicular chain abnormalities. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 874.1090 (Ear, Nose, and Throat specialty). This device is eligible for third-party 510(k) review.

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    510(k)s
    2
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    2
    Years Active
    2

    Basic Information

    Product Code
    NAS
    Device Class
    FDA class 2
    Regulation Number
    874.1090
    Medical Specialty
    Ear, Nose, Throat
    Review Panel
    EN
    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 2 510(k) clearances via K numbers.

    K Number Device Name
    K171265 Otowave 302 Portable Tympanometer
    K150163 Otowave 202 Portable Tympanometer

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.