FDA device listing
Natus
FDA device listing 1639781527 · Fideltronik Poland sp. z o.o.
Key facts
| Proprietary names | Natus |
|---|---|
| Owner/operator | Fideltronik Poland sp. z o.o. |
| Owner/operator number | 10095302 |
| Product codes | GWE, GWF, GWJ, GZP, IKN, JXE, OLT |
| Device names | GWE - Stimulator, Photic, Evoked Response, GWF - Stimulator, Electrical, Evoked Response, GWJ - Stimulator, Auditory, Evoked Response, GZP - Stimulator, Mechanical, Evoked Response, IKN - Electromyograph, Diagnostic, JXE - Device, Nerve Conduction Velocity Measurement, OLT - Non-Normalizing Quantitative Electroencephalograph Software |
| Device class | Class II |
| Classification regulations (21 CFR) | 882.1400, 882.1550, 882.1870, 882.1880, 882.1890, 882.1900, 890.1375 |
| Review panels | Neurology, Physical Medicine |
| Registered establishments | FIDELTRONIK POLAND SP. Z O.O. |
| Establishment registrations | 3011766844 |
| FEI numbers | 3011766844 |
| 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