Zen Program (Mind 440 Hearing Aid)
FDA 510(k) K080955 · Widex Hearing Aid Co., Inc.
510(k) numberK080955
Submission
- Device name
- Zen Program (Mind 440 Hearing Aid)
- Applicant
- Widex Hearing Aid Co., Inc.
Lisle, IL, US - Received
- April 3, 2008
- Decision date
- June 27, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KLW – Masker, Tinnitus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3400
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code KLW
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|---|---|---|---|
| K260413 | Levo Gen 2 Tinnitus Therapy SystemKLW · Traditional | Levo Medical Corporation | 08/13/2026SE |
| K260614 | Tinnitus TherapyKLW · Special | Sivantos GmbH | 06/10/2026SE |
| K233435 | Peace N Quiet (0.7.0)KLW · Traditional | Pnq Health | 02/27/2024SE |
| K223694 | Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)KLW · Traditional | Duearity AB | 06/30/2023SE |
| K221168 | Tinnitogram Signal GeneratorKLW · Traditional | Goldenear Company, Inc. | 02/01/2023SE |
| K221125 | SilentCloudKLW · Traditional | Aureliym GmbH | 01/04/2023SE |
| K201370 | Multiflex Tinnitus TechnologyKLW · Special | Starkey Laboratories, Inc. | 06/19/2020SE |
| K193303 | Tinnitus Sound Generator ModuleKLW · Special | GN Hearing A/S | 02/20/2020SE |
| K180495 | Tinnitus Sound Generator ModuleKLW · Traditional | GN Hearing A/S | 11/30/2018SE |
| K181586 | Tinnitus Sound Generator ModuleKLW · Special | GN Hearing A/S | 07/13/2018SE |
More from GN Hearing A/S
| 510(k) | Device | Decision |
|---|---|---|
| K971535 | Widex Senso Digital (Mini Canal)ESD · Traditional | 06/06/1997SE |
| K970904 | Widex Senso Digital (Cic)ESD · Traditional | 03/26/1997SE |
| K965254 | Widex Model Senso Digital (C9)ESD · Traditional | 03/12/1997SE |
| K965218 | Senso Digital (C18)ESD · Traditional | 01/24/1997SE |
| K955879 | Widex Model Senso Digital (C16)ESD · Traditional | 02/27/1996SE |
| K955878 | Widex Model Senso Digital (C8)ESD · Traditional | 02/12/1996SE |
| K954526 | Widex Senso Digital (PX)ESD · Traditional | 10/18/1995SE |
| K952229 | Widex Model Logo 32 (L32)ESD · Traditional | 06/19/1995SE |
| K946071 | Lx-ItcESD · Traditional | 01/30/1995SE |
| K944518 | Widex Model Logo 8SESD · Traditional | 12/27/1994SE |
Questions and answers
When was Zen Program (Mind 440 Hearing Aid) cleared by the FDA?
Zen Program (Mind 440 Hearing Aid) (K080955) received a 510(k) decision of Substantially Equivalent on June 27, 2008, 85 days after the submission was received.
What is the product code of K080955?
The FDA product code is KLW – Masker, Tinnitus, a Class II (moderate risk) device regulated under 21 CFR 874.3400.