The following data is part of a premarket notification filed by Siemens Hearing Instruments, Inc. with the FDA for Tci (tinnitus Control Instrument).
| Device ID | K003559 |
| 510k Number | K003559 |
| Device Name: | TCI (TINNITUS CONTROL INSTRUMENT) |
| Classification | Masker, Tinnitus |
| Applicant | SIEMENS HEARING INSTRUMENTS, INC. 10 CONSTITUTION AVE. P.O. BOX 1397 Piscataway, NJ 08855 |
| Contact | David S Slavin |
| Correspondent | David S Slavin SIEMENS HEARING INSTRUMENTS, INC. 10 CONSTITUTION AVE. P.O. BOX 1397 Piscataway, NJ 08855 |
| Product Code | KLW |
| CFR Regulation Number | 874.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-17 |
| Decision Date | 2001-04-26 |