Ototech, Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
5
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K011338OTO-CEMSeptember 13, 2001
K910314C ABRA MODEL LINEAR, LOW DR. CUSTOM CANAL HEAR AIDMarch 18, 1991
K910312C ABRA MODEL LINEAR, LOW DRAIN CUST CANAL HEAR AIDMarch 18, 1991
K910311ABRA MODEL LINE LOW DRAIN CUST IN-THE-EAR HEAR AIDMarch 18, 1991
K910313ABRA IPC MODEL INPUT COMPRES AGCCUST ITE HEAR AIDMarch 18, 1991