FDA device listing
Hearing Aid, Air-Conduction With Wireless Technology, Prescription
FDA device listing 1179126256 · GIGATEK INC.
Key facts
| Owner/operator | GIGATEK INC. |
|---|---|
| Owner/operator number | 10086845 |
| Product codes | OSM |
| Device names | OSM - Hearing Aid, Air-Conduction With Wireless Technology, Prescription |
| Device class | Class II |
| Classification regulations (21 CFR) | 874.3305 |
| Review panels | Ear, Nose, & Throat |
| Registered establishments | GIGATEK INC. |
| Establishment registrations | 3002686300 |
| FEI numbers | 3002686300 |
| Establishment operations | Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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