DeviceClearance

Product code EPF— Ear, Nose, Throat

PHONIC EAR

Classification name
Hearing Aid, Group And Auditory Trainer
Device class
Class 2
Regulation
21 CFR 874.3320
Advisory panel
Ear, Nose, Throat
Total cleared
32
First cleared
Most recent

Market context for product code EPF

FDA has cleared 32 devices under product code EPF between 1977 and 2014, filed by 12 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 EPF

Recent clearances under product code EPF

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