DeviceClearance

Product code ESE— Ear, Nose, Throat

ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEM

Classification name
Larynx, Artificial (Battery-Powered)
Device class
Class 1
Regulation
21 CFR 874.3375
Advisory panel
Ear, Nose, Throat
Total cleared
13
First cleared
Most recent

Market context for product code ESE

FDA has cleared 13 devices under product code ESE between 1983 and 1994, filed by 12 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code ESE

Recent clearances under product code ESE

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