Company ยท GB
Otodynamics, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2024. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EWO | Audiometer | 8 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 21, 2024 | K234095 | OtoNova/OtoNova Pro Otodynamics, GB | EWO |
| Mar 15, 2024 | K240430 | Otoport Pro Otodynamics, Ltd., GB | EWO |
| Feb 23, 2015 | K143395 | Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otochec Otodynamics, Ltd., GB | EWO |
| Nov 13, 2007 | K072033 | OTODYNAMICS OTOPORT Otodynamics, Ltd. | EWO |
| Dec 11, 1998 | K983352 | ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK Otodynamics, Ltd. | EWO |
| Dec 11, 1998 | K983351 | ILO292 DP ECHOPORT PLUS OAE SYSTEM Otodynamics, Ltd. | EWO |
| Dec 11, 1998 | K983350 | ILO292 DP ECHOPORT PLUS OAE SYSTEM Otodynamics, Ltd. | EWO |
| Jan 10, 1997 | K962995 | ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC Otodynamics, Ltd., GB | EWO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||