DeviceClearance

Product code EWO— Ear, Nose, Throat

AUDIOMETER

Classification name
Audiometer
Device class
Class 2
Regulation
21 CFR 874.1050
Advisory panel
Ear, Nose, Throat
Total cleared
235
First cleared
Most recent

Market context for product code EWO

FDA has cleared 235 devices under product code EWO between 1976 and 2024, filed by 105 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 EWO

Adverse events under product code EWO

product code EWO
Other
2
Total
2

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code EWO

1–100 of 235

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