Sophono, Inc. is one of 4783 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Sophono, Inc. - FDA 510(k) Cleared Devices
5
Total
5
Cleared
0
Denied
Sophono, Inc. has 5 FDA 510(k) cleared medical devices. Based in Lakewood, US.
Historical record: 5 cleared submissions from 2010 to 2016. Primary specialty: Ear, Nose, Throat.
Browse the FDA 510(k) cleared devices submitted by Sophono, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Sophono, Inc.
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