Otodynamics, Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
8
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K234095OtoNova/OtoNova ProJune 21, 2024
K240430Otoport ProMarch 15, 2024
K143395Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, OtocheckFebruary 23, 2015
K072033OTODYNAMICS OTOPORTNovember 13, 2007
K983352ILO2088 ENCHOCHECK OR ILO2088 OTOCHECKDecember 11, 1998
K983351ILO292 DP ECHOPORT PLUS OAE SYSTEMDecember 11, 1998
K983350ILO292 DP ECHOPORT PLUS OAE SYSTEMDecember 11, 1998
K962995ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PCJanuary 10, 1997