Sophono, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Sophono Bone Conduction Systems (S) Configuration and (M) Configuration, OTOMAG BONE CONDUCATION HEARING SYSTEM, OTOMAG BONE CONDUCTION HEARING SYSTEM
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sophono, Inc. Ear, Nose, Throat ✕
5 devices
Cleared
Jun 16, 2016
Sophono Bone Conduction Systems (S) Configuration and (M) Configuration
Ear, Nose, Throat
205d
Cleared
Nov 22, 2013
OTOMAG BONE CONDUCATION HEARING SYSTEM
Ear, Nose, Throat
130d
Cleared
Apr 08, 2013
OTOMAG BONE CONDUCTION HEARING SYSTEM
Ear, Nose, Throat
103d
Cleared
May 23, 2011
OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M)
Ear, Nose, Throat
292d
Cleared
May 18, 2010
OTOMAG BONE CONDUCTION HEARING SYSTEM
Ear, Nose, Throat
116d