Tinnitogram Signal Generator
FDA 510(k) clearance K221168 · decided 2023-02-01
Clearance details
- K-number
- K221168
- Device name
- Tinnitogram Signal Generator
- Applicant
- Goldenear Company, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-04-22
- Decision date
- 2023-02-01
- Days to decision
- 285 days
- Clearance type
- Traditional
- Product code
- KLW
- Device class
- 2
- Regulation number
- 874.3400
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Santa Clarita, CA, US
- Third-party review
- No
- Expedited review
- No
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| Tinnitus Sound Generator Module (K193303) | GN Hearing A/S | 2020-02-20 |
| Tinnitus Sound Generator Module (K180495) | GN Hearing A/S | 2018-11-30 |
| Tinnitus Sound Generator Module (K181586) | GN Hearing A/S | 2018-07-13 |
| audifon Tinnitus-Module (K171243) | Audiofon USA, Inc. | 2017-10-19 |
| TinniLogic Mobile Tinnitus Management Device (K163094) | Jiangsu Betterlife Medical Co., Ltd. | 2017-05-17 |
| Sound Options Tinnitus Treatment (K161562) | Sound Options Tinnitus Treatments, Inc. | 2016-09-28 |
| HyperSound Tinnitus Module (K161331) | Turtle Beach Corporation | 2016-08-23 |
Recalls involving this device
No recalls on record reference this clearance.