Interacoustics AS - FDA 510(k) Cleared Devices
Recent clearances: EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE, TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE, ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS.
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Interacoustics AS Ear, Nose, Throat ✕
4 devices
Cleared
Jul 22, 2009
EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE
Ear, Nose, Throat
155d
Cleared
Apr 09, 2009
TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440...
Ear, Nose, Throat
106d
Cleared
Dec 23, 2005
ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS.
Ear, Nose, Throat
95d
Cleared
Feb 04, 2005
AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS
Ear, Nose, Throat
74d