Bernafon LLC
Somerset, NJ, US
Bernafon LLC appears in FDA device records in Somerset, NJ. FDA records list 16 510(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 16 510(k) clearances for Bernafon LLC between 1983 and 1988. The busiest year on record is 1984, with 4. The most recent is 1988, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 2 |
| 1984 | 4 |
| 1985 | 4 |
| 1986 | 3 |
| 1987 | 2 |
| 1988 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K880349 | MODEL 759 CUSTOM IN-THE-EAR HEARING AID | ESD | Substantially Equivalent | |
| K874589 | BERNAFON COLIBRI, C-2H HEARING AIDS | ESD | Substantially Equivalent | |
| K864823 | BEHIND THE EAR HEARING AIDS, BERNAFON COLIBRI, C1 | ESD | Substantially Equivalent | |
| K864180 | INTEGRA, CUSTOM IN-THE-EAR HEARING AID | ESD | Substantially Equivalent | |
| K860759 | CHARISMA HEARING AID | ESD | Substantially Equivalent | |
| K855240 | BEHIND THE EAR HEARING AIDS MODEL | ESD | Substantially Equivalent | |
| K851547 | BEHIND THE EAR HEARING AID MODEL BERNAFON T-82 | ESD | Substantially Equivalent | |
| K844985 | IN THE EAR MODEL X-ITE 84 | ESD | Substantially Equivalent | |
| K844621 | BEHIND THE EAR HEARING AID BERNAFON T-88P | ESD | Substantially Equivalent | |
| K844425 | BEHIND THE EAR HEARING AIDS BERNAFON X-13 | ESD | Substantially Equivalent | |
| K842546 | CUSTOM CANAL HEARING AID X-CITE 84 | ESD | Substantially Equivalent | |
| K842434 | BEHING THE EAR HEARING AID T-98 | ESD | Substantially Equivalent | |
| K840480 | BEHIND THE EAR HEARING AID T-97 | ESD | Substantially Equivalent | |
| K840479 | BEHING-THE-EAR HEARING AID T-85D | ESD | Substantially Equivalent | |
| K833775 | BEHIND-THE-EAR HEARING AIDS T-87 & | ESD | Substantially Equivalent | |
| K831217 | MODEL BERNAFON T-86 | ESD | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004644749 | 3004644749 | Bernafon LLC | 580 Howard Ave, Somerset, NJ 08873 US | 2026 | No device listings on this registration |
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