510(k) K981704
- Device
- AUREX-3
- Applicant
- ADM TRONICS UNLTD, INC.
- 510(k) number
- K981704
- Product code
- KLW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-08-05
- Date received
- 1998-05-14
- Regulation
- 874.3400
- Classification name
- Masker, Tinnitus
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAMES E LENICK
- Address
- P.O. Box 2002 Morristown TN US 37816 37816
FDA Registration Numbers#
- 2430101
- 3020981894
- 3005019184
- 2182204
- 3027487235
- 8021514
- 3042957826
- 3005650109
- 3005085999
- 2240713
- 3004929038
- 3011927597
- 3003303986
- 3006312495
- 3017441596
- 3009307953
- 3021916254
- 3038593312
- 3005465494
- 3006544364
- 3008848788
- 3010197022
- 3002808415
- 2125608
- 3036679760
- 3003426343
- 3013294311
- 3002159143
- 3019622583
- 3020982310
- 3026390997
- 3002686300
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KLW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233435 | Peace N Quiet (0.7.0) | Pnq Health | 2024-02-27 |
| K223694 | Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) | Duearity AB | 2023-06-30 |
| K221168 | Tinnitogram Signal Generator | Goldenear Company, Inc. | 2023-02-01 |
| K221125 | SilentCloud | Aureliym GmbH | 2023-01-04 |
| K201370 | Multiflex Tinnitus Technology | Starkey Laboratories, Inc. | 2020-06-19 |
| K193303 | Tinnitus Sound Generator Module | GN Hearing A/S | 2020-02-20 |
| K180495 | Tinnitus Sound Generator Module | GN Hearing A/S | 2018-11-30 |
| K181586 | Tinnitus Sound Generator Module | GN Hearing A/S | 2018-07-13 |
| K171243 | audifon Tinnitus-Module | Audiofon USA, Inc. | 2017-10-19 |
| K163094 | TinniLogic Mobile Tinnitus Management Device | Jiangsu Betterlife Medical Co., Ltd. | 2017-05-17 |
| K161562 | Sound Options Tinnitus Treatment | Sound Options Tinnitus Treatments, Inc. | 2016-09-28 |
| K161331 | HyperSound Tinnitus Module | Turtle Beach Corporation | 2016-08-23 |
| K151558 | Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System | Neurotherapies Reset GmbH | 2016-01-20 |
| K151719 | REVE134 | Kw Ear Lab, Inc. | 2015-10-09 |
| K150014 | Serenity | Sanuthera, Inc. | 2015-07-27 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases