Phonak, Inc.
Warrenville, IL, US
Phonak, Inc. appears in FDA device records in Warrenville, IL. FDA records list 39 510(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
- 39
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 39 510(k) clearances for Phonak, Inc. between 1990 and 2013. The busiest year on record is 1991, with 11. The most recent is 2013, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 4 |
| 1991 | 11 |
| 1992 | 5 |
| 1993 | 4 |
| 1994 | 3 |
| 1995 | 4 |
| 1996 | 3 |
| 1997 | 3 |
| 2013 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K130790 | LYRIC2 | ESD | Substantially Equivalent | |
| K123450 | PHONAK TINNITUS BALANCE | KLW | Substantially Equivalent | |
| K972106 | PHONAK NOVO FORTE E3 | ESD | Substantially Equivalent | |
| K972105 | PHONAK EPICA | ESD | Substantially Equivalent | |
| K972097 | PHONAK MICROZOOM P 2 | ESD | Substantially Equivalent | |
| K964035 | PHONAK MICROLINK, PERSONAL FM RECEIVER | ESD | Substantially Equivalent | |
| K961653 | PHONAK SONA P2 | ESD | Substantially Equivalent | |
| K961622 | PHONAK PICONET2 P2 AZ | ESD | Substantially Equivalent | |
| K953921 | PHONAK 9900 CIC | ESD | Substantially Equivalent | |
| K945439 | PHONAK PICONET 232X-AZ HEARING INSTRUMENT | ESD | Substantially Equivalent | |
| K950758 | DYNA 231X | ESD | Substantially Equivalent | |
| K946294 | PHONAK SONO-FORTE 332X-AZ | ESD | Substantially Equivalent | |
| K941768 | PHONAK MICROVOX RESONAL FM SYSTEM | EPF | Substantially Equivalent | |
| K941734 | PHONAK SONO-FORTE 331X BTE HEARING INSTRUMENTS | ESD | Substantially Equivalent | |
| K935791 | PHONAK PICONET 232X-AZ BTE HEARING INSTRUMENT | ESD | Substantially Equivalent | |
| K932735 | PHONAK PICO-FORTE SC-D-2 | ESD | Substantially Equivalent | |
| K932734 | PHONAK PICO-FORTE SC-2 | ESD | Substantially Equivalent | |
| K932175 | PHONAK LEXA 231X ITE SERIES HEARING SINSTRUMENT | ESD | Substantially Equivalent | |
| K930145 | PHONAK PICONET 231-X | ESD | Substantially Equivalent | |
| K924914 | PHONAK PICO-FORTE PPC-P-2 BTE HEARING INSTRUMENT | ESD | Substantially Equivalent | |
| K924913 | PHONAK PICO-FORTE PPC-L-P-2 BTE HEARING INSTR | ESD | Substantially Equivalent | |
| K924911 | PHONAK PICO-FORTE PP-SC-2 BTE HEARING INSTRUMENT | ESD | Substantially Equivalent | |
| K924912 | PHONAK PICO-FORTE C-2 BTE HEARING INSTRUMENT | ESD | Substantially Equivalent | |
| K923743 | BTE WITH ACCESSORY ATTACHED | ESD | Substantially Equivalent | |
| K915461 | PHONAK 9000-AF ITE HEARING INSTRUMENT SERIES | ESD | Substantially Equivalent | |
| K913503 | PHONAK PICO-FORTE PP-C-P BTE HEARING INSTRUMENT | ESD | Substantially Equivalent | |
| K913502 | PHONAK AUDINET PP-C-P BTE HEARING INSTRUMENT | ESD | Substantially Equivalent | |
| K912571 | PHONAK PHONICA MODEL 312-SC ITE HEARING INSTRUMENT | ESD | Substantially Equivalent | |
| K912570 | PHONAK PHONICA MODEL 312-C ITE HEARING INSTRUMENT | ESD | Substantially Equivalent | |
| K911211 | PHONAK 9100 SC-AF ITE HEARING INSTRUMENT | ESD | Substantially Equivalent | |
| K911210 | PHONAK 9800 SC-AF ITE HEARING INSTRUMENT | ESD | Substantially Equivalent | |
| K911209 | PHONAK 9300 SC-AF ITE HEARING INSTRUMENT | ESD | Substantially Equivalent | |
| K910028 | POST AURICULAR HEARING AID MODEL PICO SC-H | ESD | Substantially Equivalent | |
| K910018 | POST AURICULAR HEARING AID MODEL PICO-FORTE PP-SC | ESD | Substantially Equivalent | |
| K910012 | PHONAK MODEL PICO C-S-H-T, BTE HEARING AID | ESD | Substantially Equivalent | |
| K900831 | BTE PICO SCD, PICO SC | ESD | Substantially Equivalent | |
| K900830 | BTE SUPER-FRONT PPCL4, SUPER-FRONT PPC4 | ESD | Substantially Equivalent | |
| K900829 | BTE SUPER-FRONT PPSCL, SUPER-FRONT PPSC | ESD | Substantially Equivalent | |
| K900675 | PHONAK ITE 8000, 7000, 6000 ITE HEARING AID | 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