Company ยท US
Ototech, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2001. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 13, 2001 | K011338 | OTO-CEM Ototech, Inc. | NEA |
| Mar 18, 1991 | K910314 | C ABRA MODEL LINEAR, LOW DR. CUSTOM CANAL HEAR AID Ototech, Ltd. | ESD |
| Mar 18, 1991 | K910313 | ABRA IPC MODEL INPUT COMPRES AGCCUST ITE HEAR AID Ototech, Ltd. | ESD |
| Mar 18, 1991 | K910312 | C ABRA MODEL LINEAR, LOW DRAIN CUST CANAL HEAR AID Ototech, Ltd. | ESD |
| Mar 18, 1991 | K910311 | ABRA MODEL LINE LOW DRAIN CUST IN-THE-EAR HEAR AID Ototech, Ltd. | ESD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||