The following data is part of a premarket notification filed by Phonak Llc with the FDA for Phonak Tinnitus Balance.
| Device ID | K123450 |
| 510k Number | K123450 |
| Device Name: | PHONAK TINNITUS BALANCE |
| Classification | Masker, Tinnitus |
| Applicant | PHONAK LLC 4520 WEAVER PARKWAY Warrenville, IL 60555 |
| Contact | Laura Ellman |
| Correspondent | Laura Ellman PHONAK LLC 4520 WEAVER PARKWAY Warrenville, IL 60555 |
| Product Code | KLW |
| CFR Regulation Number | 874.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-09 |
| Decision Date | 2013-02-11 |
| Summary: | summary |