Otodynamics, Ltd.
HATFIELD, HERTS Hertfordshire, GB
OTODYNAMICS, LTD. appears in FDA device records in HATFIELD, HERTS Hertfordshire, GB. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Otodynamics, Ltd. between 1997 and 2024. The busiest year on record is 1998, with 3. The most recent is 2024, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 1 |
| 1998 | 3 |
| 2007 | 1 |
| 2015 | 1 |
| 2024 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K234095 | OtoNova/OtoNova Pro | EWO | Substantially Equivalent | |
| K240430 | Otoport Pro | EWO | Substantially Equivalent | |
| K143395 | Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit | EWO | Substantially Equivalent | |
| K072033 | OTODYNAMICS OTOPORT | EWO | Substantially Equivalent | |
| K983352 | ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK | EWO | Substantially Equivalent | |
| K983351 | ILO292 DP ECHOPORT PLUS OAE SYSTEM | EWO | Substantially Equivalent | |
| K983350 | ILO292 DP ECHOPORT PLUS OAE SYSTEM | EWO | Substantially Equivalent | |
| K962995 | ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC | EWO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8021990 | 2939 | OTODYNAMICS, LTD. | 30-38 BEACONSFIELD RD., HATFIELD, HERTS Hertfordshire AL10 8BB GB | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain