DeviceClearance

Product code ETY— Ear, Nose, Throat

Hearing Healthcare Pro

Classification name
Tester, Auditory Impedance
Device class
Class 2
Regulation
21 CFR 874.1090
Advisory panel
Ear, Nose, Throat
Total cleared
70
First cleared
Most recent

Market context for product code ETY

FDA has cleared 70 devices under product code ETY between 1980 and 2019, filed by 37 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

last 15 years

Top applicants under product code ETY

Recent clearances under product code ETY

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