Electone, Inc.
Mchenry, IL, US
Electone, Inc. appears in FDA device records in Mchenry, IL. FDA records list 73 510(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
- 73
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 73FDA records hold 73 510(k) clearances for Electone, Inc. between 1981 and 1997. The busiest year on record is 1991, with 14. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 1 |
| 1983 | 3 |
| 1984 | 1 |
| 1985 | 2 |
| 1986 | 7 |
| 1987 | 4 |
| 1989 | 2 |
| 1991 | 14 |
| 1992 | 9 |
| 1993 | 13 |
| 1994 | 2 |
| 1995 | 12 |
| 1996 | 2 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K973266 | Z DEQ-II | ESD | Substantially Equivalent | |
| K961084 | AM 400 | ESD | Substantially Equivalent | |
| K955702 | SONATA U-01 | ESD | Substantially Equivalent | |
| K953050 | Z33 | ESD | Substantially Equivalent | |
| K953047 | Z20 | ESD | Substantially Equivalent | |
| K953054 | AM 260 OHM | ESD | Substantially Equivalent | |
| K953053 | AM 260 PP | ESD | Substantially Equivalent | |
| K953052 | AM 260 K-AMP | ESD | Substantially Equivalent | |
| K953051 | Z35 | ESD | Substantially Equivalent | |
| K953049 | Z24 | ESD | Substantially Equivalent | |
| K953048 | Z22 | ESD | Substantially Equivalent | |
| K951642 | GOLD CD ULTRA MINI CANAL - MODULE | ESD | Substantially Equivalent | |
| K950458 | SILVER ULTRA MINI CANAL | ESD | Substantially Equivalent | |
| K950460 | GOLD CD ULTRA MINI CANAL | ESD | Substantially Equivalent | |
| K950459 | GOLD K AMP ULTRA MINI CANAL | ESD | Substantially Equivalent | |
| K942722 | MODULE PROGRAM | LRB | Substantially Equivalent | |
| K941133 | 770-ATC | ESD | Substantially Equivalent | |
| K933046 | SILVER L MODULE, ITE | LRB | Substantially Equivalent | |
| K933045 | SILVER RECHARGEABLE MODULE, ITE | LRB | Substantially Equivalent | |
| K933044 | SILVER LD MODULE, ITE | LRB | Substantially Equivalent | |
| K933043 | SILVER PPP MODULE, ITE | LRB | Substantially Equivalent | |
| K933042 | SILVER COMPRESSION MODULE, ITE | ESD | Substantially Equivalent | |
| K933041 | COLD CD ASP MODULE, ITE | LRS | Substantially Equivalent | |
| K933040 | GOLD CD MODULE, ITE | LRB | Substantially Equivalent | |
| K933039 | GOLD L MODULE, ITE | LRB | Substantially Equivalent | |
| K933038 | GOLD AF MODULE, ITE | LRB | Substantially Equivalent | |
| K933037 | GOLD K AMP, ITE | LRB | Substantially Equivalent | |
| K933036 | GOLD ASP MODULE, ITE | ESD | Substantially Equivalent | |
| K922502 | M32 IN THE EAR HEARING AID | ESD | Substantially Equivalent | |
| K922501 | M30 IN THE EAR HEARING AID | ESD | Substantially Equivalent | |
| K924888 | P54 HEARING AID | ESD | Substantially Equivalent | |
| K924887 | P54-0 BEHIND THE EAR HEARING AID | ESD | Substantially Equivalent | |
| K914948 | AM 300 AGC-O | ESD | Substantially Equivalent | |
| K914947 | AM 300 XP | ESD | Substantially Equivalent | |
| K914799 | PREMIER K-AMP | ESD | Substantially Equivalent | |
| K914798 | PREMIER CLASS D-ASP | ESD | Substantially Equivalent | |
| K914797 | PREMIER CD RECHARGEABLE | ESD | Substantially Equivalent | |
| K914796 | PREMIER ASP/CD RECHARGEABLE | ESD | Substantially Equivalent | |
| K914795 | ELECTONE/PA RECHARGEABLE | ESD | Substantially Equivalent | |
| K911709 | STOCK CANAL, IN-THE-EAR HEARING AID | ESD | Substantially Equivalent | |
| K911708 | MODEL E-50, IN-THE-EAR HEARING AID | ESD | Substantially Equivalent | |
| K911707 | REGAL, BEHIND-THE-EAR HEARING AID | ESD | Substantially Equivalent | |
| K911706 | MODEL 800, BEHIND-THE-EAR HEARING AID | ESD | Substantially Equivalent | |
| K911705 | CHAMPION, BEHIND-THE-EAR HEARING AID | ESD | Substantially Equivalent | |
| K910097 | ELECTONE ITE MODEL PREMIER | ESD | Substantially Equivalent | |
| K910148 | AM130 AGC-O (BEHIND THE EAR) HEARING AID | ESD | Substantially Equivalent | |
| K910103 | ELECTONE BTE MODEL AM 130 HF | ESD | Substantially Equivalent | |
| K910102 | ELECTONE BTE MODEL AM 240 PPL | ESD | Substantially Equivalent | |
| K910101 | ELECTONE BTE MODEL AM 130 PP | ESD | Substantially Equivalent | |
| K910100 | ELECTONE BTE MODEL AM 130 D | ESD | 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