FDA device listing
Natus Synergy Focus,Synergy Focus,UltraPro S100
FDA device listing 1334070799 · Natus Medical Incorporated
Key facts
| Proprietary names | Natus Synergy Focus,Synergy Focus,UltraPro S100 |
|---|---|
| Owner/operator | Natus Medical Incorporated |
| Owner/operator number | 9004873 |
| Premarket submissions | K130346 |
| Product codes | GWE, GWF, GWJ, GXP, IKN, JXE, OLT |
| Device names | GWE - Stimulator, Photic, Evoked Response, GWF - Stimulator, Electrical, Evoked Response, GWJ - Stimulator, Auditory, Evoked Response, GXP - Methyl Methacrylate For Cranioplasty, 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, 882.1890, 882.1900, 882.5300, 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 | Contract 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