Otodynamics, Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Otoport Pro, Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit, OTODYNAMICS OTOPORT
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Otodynamics, Ltd. Ear, Nose, Throat ✕
7 devices
Cleared
Mar 15, 2024
Otoport Pro
Ear, Nose, Throat
30d
Cleared
Feb 23, 2015
Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR...
Ear, Nose, Throat
89d
Cleared
Nov 13, 2007
OTODYNAMICS OTOPORT
Ear, Nose, Throat
112d
Cleared
Dec 11, 1998
ILO292 DP ECHOPORT PLUS OAE SYSTEM
Ear, Nose, Throat
79d
Cleared
Dec 11, 1998
ILO292 DP ECHOPORT PLUS OAE SYSTEM
Ear, Nose, Throat
79d
Cleared
Dec 11, 1998
ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK
Ear, Nose, Throat
79d
Cleared
Jan 10, 1997
ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC
Ear, Nose, Throat
162d