BEUDAMED
    Product Code: EQL FDA class 1 21 CFR 874.4750

    Laryngostroboscope

    Ear, Nose, Throat

    The laryngostroboscope is a diagnostic instrument that uses a stroboscopic light source to examine the vibratory motion of the vocal cords, enabling assessment of voice disorders and laryngeal pathology. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is EQL, regulated under 21 CFR 874.4750 in the Ear, Nose, Throat specialty. No special regulatory flags apply.

    View on FDA
    510(k)s
    8
    FEI Numbers
    36
    Registration Numbers
    36
    Unique Applicants
    7
    Years Active
    22

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    Basic Information

    Product Code
    EQL
    Device Class
    FDA class 1
    Regulation Number
    874.4750
    Medical Specialty
    Ear, Nose, Throat
    Review Panel
    EN
    Submission Type
    4

    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 8 510(k) clearances via K numbers.

    K Number Device Name
    K984521 RIWO DRIVE SYSTEM 2302 WITH GENERATOR, SMALL MOTOR HANDLES, 8563.111, 8563.351
    K921285 9105 RIGID TELESCOPIC ENDOSCOPE
    K921184 RLS 9100 RHINO-LARYNGEAL STROBOSCOPE
    K884933 ENDOSTROBOSCOPE IV
    K842090 RHINO-LARYNX STROBOSCOPE TYPE 4914
    K822523 LARYNGOSTROBOSCOPE
    K801866 PENTAX LARYNGO-STROBOSCOPE MODEL LS-1A
    K770466 STOCKINGS, RVS TM

    FEI Numbers

    This FDA classification entry is associated with 36 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 36 registration numbers. Click on an entry to view related FDA registrations.