FDA device listing
UltraPro S100 with Integrated Ultrasound
FDA device listing 1826724613 · Natus Medical Incorporated
Key facts
| Proprietary names | UltraPro S100 with Integrated Ultrasound |
|---|---|
| Owner/operator | Natus Medical Incorporated |
| Owner/operator number | 9004873 |
| Premarket submissions | K243495 |
| 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 | Natus Manufacturing Limited, Natus Neurology Incorporated |
| Establishment registrations | 3005581270, 3010611950 |
| FEI numbers | 3005581270, 3010611950 |
| Establishment operations | Manufacturer, Specification Developer |
| 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