AUREX-3
FDA 510(k) clearance K981704 · decided 1998-08-05
Clearance details
- K-number
- K981704
- Device name
- AUREX-3
- Applicant
- Adm Tronics Unltd, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-05-14
- Decision date
- 1998-08-05
- Days to decision
- 83 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
- Morristown, TN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Adm Tronics Unltd
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Tinnitus Therapy (K260614) | Sivantos GmbH | 2026-06-10 |
| Peace N Quiet (0.7.0) (K233435) | Pnq Health | 2024-02-27 |
| Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) (K223694) | Duearity AB | 2023-06-30 |
| Tinnitogram Signal Generator (K221168) | Goldenear Company, Inc. | 2023-02-01 |
| SilentCloud (K221125) | Aureliym GmbH | 2023-01-04 |
| Multiflex Tinnitus Technology (K201370) | Starkey Laboratories, Inc. | 2020-06-19 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.