DeviceClearance

Product code ETS— Ear, Nose, Throat

AUDITORY LOCALIZER

Classification name
Generator, Electronic Noise (For Audiometric Testing)
Device class
Class 2
Regulation
21 CFR 874.1120
Advisory panel
Ear, Nose, Throat
Total cleared
5
First cleared
Most recent

Market context for product code ETS

FDA has cleared 5 devices under product code ETS between 1977 and 1982, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code ETS

Recent clearances under product code ETS

Data sourced from openFDA. This site is unofficial and independent of the FDA.