DeviceClearance

Product code ETW— Ear, Nose, Throat

AUDIOMETER

Classification name
Calibrator, Hearing Aid / Earphone And Analysis Systems
Device class
Class 2
Regulation
21 CFR 874.3310
Advisory panel
Ear, Nose, Throat
Total cleared
46
First cleared
Most recent

Market context for product code ETW

FDA has cleared 46 devices under product code ETW between 1980 and 2012, filed by 25 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 ETW

Recent clearances under product code ETW

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