The following data is part of a premarket notification filed by General Hearing Instruments, Inc. with the FDA for Tranquil Tri-bte.
| Device ID | K061459 |
| 510k Number | K061459 |
| Device Name: | TRANQUIL TRI-BTE |
| Classification | Masker, Tinnitus |
| Applicant | GENERAL HEARING INSTRUMENTS, INC. P.O. BOX 23748 New Orleans, LA 70183 -0748 |
| Contact | Roger P Juneau |
| Correspondent | Roger P Juneau GENERAL HEARING INSTRUMENTS, INC. P.O. BOX 23748 New Orleans, LA 70183 -0748 |
| Product Code | KLW |
| CFR Regulation Number | 874.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-26 |
| Decision Date | 2006-06-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00089518000801 | K061459 | 000 |
| 00089518000351 | K061459 | 000 |
| 00089518000344 | K061459 | 000 |
| 00089518000337 | K061459 | 000 |
| 00089518000320 | K061459 | 000 |
| 00089518000313 | K061459 | 000 |
| 00089518000306 | K061459 | 000 |
| 00089518000290 | K061459 | 000 |
| 00089518000283 | K061459 | 000 |
| 00089518000276 | K061459 | 000 |
| 00089518000269 | K061459 | 000 |
| 00089518000252 | K061459 | 000 |
| 00089518000245 | K061459 | 000 |
| 00089518000238 | K061459 | 000 |
| 00089518000221 | K061459 | 000 |
| 00089518000368 | K061459 | 000 |
| 00089518000375 | K061459 | 000 |
| 00089518000382 | K061459 | 000 |
| 00089518000795 | K061459 | 000 |
| 00089518000788 | K061459 | 000 |
| 00089518000504 | K061459 | 000 |
| 00089518000498 | K061459 | 000 |
| 00089518000481 | K061459 | 000 |
| 00089518000474 | K061459 | 000 |
| 00089518000467 | K061459 | 000 |
| 00089518000450 | K061459 | 000 |
| 00089518000443 | K061459 | 000 |
| 00089518000436 | K061459 | 000 |
| 00089518000429 | K061459 | 000 |
| 00089518000412 | K061459 | 000 |
| 00089518000405 | K061459 | 000 |
| 00089518000399 | K061459 | 000 |
| 00089518000214 | K061459 | 000 |