ETS

Generator, Electronic Noise (For Audiometric Testing)

Product code: ETS
Device name: Generator, Electronic Noise (For Audiometric Testing)
Device class: Class 2
21 CFR: 21 CFR 874.1120
Medical specialty: Ear, Nose, Throat
Marketing pathway: 510(K) Exempt
510(k) clearances (all years, FDA): 5 (all years; only the last 3 years are listed here)

Official FDA classification page: ETS

Classification and pathway per current FDA publications. Data from openFDA (CC0).