| Device Type ID | 1581 |
| Device Name | Masker, Tinnitus |
| Regulation Description | Tinnitus Masker. |
| Regulation Medical Specialty | Ear Nose & Throat |
| Review Panel | Ear Nose & Throat |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Ear, Nose, And Throat Devices Branch (ENTB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 874.3400 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KLW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 1581 |
| Device | Masker, Tinnitus |
| Product Code | KLW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Tinnitus Masker. |
| CFR Regulation Number | 874.3400 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AMPLISOUND HEARING PRODUCTS & SERVICES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
AUDIOFON USA INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GN HEARING A/S | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
GN RESOUND A/S | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GN RESOUND A/S (CORPORATE HEADQUARTERS) | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HANSATON AKUSTIK GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
JIANGSU BETTERLIFE MEDICAL CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KW EAR LAB, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NEUROTHERAPIES RESET GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OTICON A/S | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OTOHARMONICS CORP | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SOUND OPTIONS TINNITUS TREATMENTS INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SOUNDCURE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |