ESE · Class I · 21 CFR 874.3375

FDA Product Code ESE: Larynx, Artificial (battery-powered)

Leading manufacturers include Xomed, Inc. and Bear Medical Systems, Inc..

13
Total
13
Cleared
127d
Avg days
1983
Since

FDA 510(k) Cleared Larynx, Artificial (battery-powered) Devices (Product Code ESE)

13 devices
1–13 of 13
Cleared Jan 24, 1984
BEAR VENTI--VOICE
K834555
Bear Medical Systems, Inc.
Ear, Nose, Throat · 28d
Cleared Jul 28, 1983
INTRA-ORAL ARTIFICIAL LARYNX
K831127
Xomed, Inc.
Ear, Nose, Throat · 113d

About Product Code ESE - Regulatory Context