Medical Device Manufacturer · US , Minneapolis , MN

Ototech, Ltd. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 1991

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ototech, Ltd. Ear, Nose, Throat ✕

4 devices

1-4 of 4

Cleared Mar 18, 1991

ABRA MODEL LINE LOW DRAIN CUST IN-THE-EAR HEAR AID

Ear, Nose, Throat · 53d

Cleared Mar 18, 1991

C ABRA MODEL LINEAR, LOW DRAIN CUST CANAL HEAR AID

Ear, Nose, Throat · 53d

Cleared Mar 18, 1991

ABRA IPC MODEL INPUT COMPRES AGCCUST ITE HEAR AID

Ear, Nose, Throat · 53d

Cleared Mar 18, 1991

C ABRA MODEL LINEAR, LOW DR. CUSTOM CANAL HEAR AID

Ear, Nose, Throat · 53d