FDA device listing
Afflelou Incognito GS AI,Afflelou Incognito OM AI+,Amplifon AMPLI-MINI,Amplifon AMPLI-POWER,Audibel Aris AI+,Audibel A…
FDA device listing 1184990517 · Starkey Laboratories, Inc.
Key facts
| Proprietary names | Afflelou Incognito GS AI,Afflelou Incognito OM AI+,Amplifon AMPLI-MINI,Amplifon AMPLI-POWER,Audibel Aris AI+,Audibel A Series AI,AudioSync Aris AI+,AudioSync A Series AI,Miracle Ear Custom Tinnitus,Miracle Ear Custom Tinnitus +,Miracle-Ear MEMINI,Miracle-Ear MEPOWER,NuEar NE Series AI,NuEar Noble AI+,OuieZen GS AI,OuieZen OM AI+,SoundGear AMP 2,Starkey G Series AI,Starkey Multiflex Tinnitus… |
|---|---|
| Owner/operator | Starkey Laboratories, Inc. |
| Owner/operator number | 2125608 |
| Premarket submissions | K201370 |
| Product codes | KLW |
| Device names | KLW - Masker, Tinnitus |
| Device class | Class II |
| Classification regulations (21 CFR) | 874.3400 |
| Review panels | Ear, Nose, & Throat |
| Registered establishments | STARKEY DE MEXICO, S.A. DE C.V., Starkey Global Distribution Center, Starkey Laboratories, Inc., STARKEY (Suzhou) Hearing Technology Co, LTD. |
| Establishment registrations | 2125608, 3002159143, 3006544364, 3019622583 |
| FEI numbers | 2125608, 3002159143, 3006544364, 3019622583 |
| Establishment operations | Manufacturer, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database