Beltone Electronics Corp.
Walker, MI, US
Beltone Electronics Corp. appears in FDA device records in Walker, MI. FDA records list 42 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 42
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 42 510(k) clearances for Beltone Electronics Corp. between 1980 and 1997. The busiest year on record is 1994, with 13. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 1 |
| 1985 | 1 |
| 1988 | 1 |
| 1991 | 4 |
| 1992 | 5 |
| 1993 | 8 |
| 1994 | 13 |
| 1995 | 6 |
| 1996 | 2 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K971852 | AIR CONDUCTION HAEARING AIDS | ESD | Substantially Equivalent | |
| K963958 | IMPRESS, PERFECTA, ACU-FORM, AND ACUFIT | ESD | Substantially Equivalent | |
| K955930 | BELTONE COMPOSER 2000 BTE HP | ESD | Substantially Equivalent | |
| K954936 | BELTONE ULTIMA 80 OTOSONIC POWER PAS | ESD | Substantially Equivalent | |
| K943616 | BELTONE PERSONAL HEARING SCREENER | EWO | Substantially Equivalent | |
| K951587 | BELTONE PETITE PLUS BELTONE PETITE PLUS CLEARVIOCE K | ESD | Substantially Equivalent | |
| K952097 | OTOSONIC (OSI) CF 10-K, 10-D | ESD | Substantially Equivalent | |
| K950868 | BELTONE COMPOSER 2000 | ESD | Substantially Equivalent | |
| K946340 | BELTONE COMPARAFIT | ESD | Substantially Equivalent | |
| K944502 | BELTONE CONCERTO S | ESD | Substantially Equivalent | |
| K942716 | AUDIO EXPERT AUDIOMETER | EWO | Substantially Equivalent | |
| K940216 | BELTONE SERIES 100 AUDIOMETERS | EWO | Substantially Equivalent | |
| K942213 | OPTIMA WITH DELTA AMP | ESD | Substantially Equivalent | |
| K940098 | BELTONE INVISA | ESD | Substantially Equivalent | |
| K941395 | BELTON MERIT (HEARING AID) | ESD | Substantially Equivalent | |
| K940177 | OTOSONIC CF-2, CF-2 IC, CF-2 ANF, CF-2 WITH IMPROVED CLASS D (DELTA AMP) | ESD | Substantially Equivalent | |
| K940103 | BELTONE ODE AND BELTONE ODE VX; ODE CLEARVOICE IC AND BELTONE ODE VX CLEARVOICE IC; BELTONE ODE CLEARVOICE ANF AND | ESD | Substantially Equivalent | |
| K940102 | BELTONE OPERA/OPERA MHP/OPERA MAX | ESD | Substantially Equivalent | |
| K940101 | OTOSONIC ACS II D WITH SRR | ESD | Substantially Equivalent | |
| K940100 | PROFILE IC; PROFILE CLEARVOICE; PROFILE | ESD | Substantially Equivalent | |
| K940099 | OTOSONIC (OSI) LPS D; LPS D IC; LPS D ASP | ESD | Substantially Equivalent | |
| K940104 | OTOSONIC MINI PAS | ESD | Substantially Equivalent | |
| K934618 | OTOSONIC ADVANCED FULL SHIELD (AFS) | ESD | Substantially Equivalent | |
| K932703 | BELTONE PRIMA 2000 | ESD | Substantially Equivalent | |
| K932426 | BELTONE OPERA/OPERA MHP/OPERA MAX | ESD | Substantially Equivalent | |
| K932058 | BELTONE OPTIMA 2000 ITE HEARING AID | ESD | Substantially Equivalent | |
| K931881 | IN THE CANAL AID OTOSONIC ACS II WITH SRR | ESD | Substantially Equivalent | |
| K930598 | OTOSONIC FSD, IN-THE-EAR HEARING AID | ESD | Substantially Equivalent | |
| K930318 | BELTONE OPERA LOR, ITC | ESD | Substantially Equivalent | |
| K930310 | BELTONE OPTIMA 2000 CLEARVOICE SERIES, IN-THE-EAR | ESD | Substantially Equivalent | |
| K922827 | OTOSONIC ACS K | ESD | Substantially Equivalent | |
| K922301 | BELTONE OPERA CLEARVOICE IC, ITC (IN THE CANAL) | ESD | Substantially Equivalent | |
| K922224 | OTOSONIC ACS-IC | ESD | Substantially Equivalent | |
| K915323 | THE BELTONE AUDIO SCOUT | EWO | Substantially Equivalent | |
| K921023 | BELTONE OPRA CLEAR VOICE-K HEARING AID | ESD | Substantially Equivalent | |
| K914982 | BELTONE PROFILE IN-THE-EAR HEARING AID | ESD | Substantially Equivalent | |
| K914981 | OTOSONIC (OSI) LPS IN-THE-EAR HEARING AID | ESD | Substantially Equivalent | |
| K914940 | BELTONE CLEARVOICE | ESD | Substantially Equivalent | |
| K914939 | OTOSONIC ACS-ASP | ESD | Substantially Equivalent | |
| K875360 | THE BELTONE 2000 AUDIOMETER | EWO | Substantially Equivalent | |
| K854001 | CERTI-FORM | ESD | Substantially Equivalent | |
| K800784 | MINUET MASKER; JUBILEE MASKER | KLW | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
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