FDA device listing
025420 PMIO Patient Bedside Monitor Cable,025430 AC Power Adapter,025440 USB-to-RS232 Adapter Cable,026950 14.4V Li-ion…
FDA device listing 1931539437 · Natus Medical Incorporated
Key facts
| Proprietary names | 025420 PMIO Patient Bedside Monitor Cable,025430 AC Power Adapter,025440 USB-to-RS232 Adapter Cable,026950 14.4V Li-ion Battery,CAM02 Camino ICP Monitor,CAMCABL Camino Fiber Optic Catheter Cable |
|---|---|
| Owner/operator | Natus Medical Incorporated |
| Owner/operator number | 9004873 |
| Premarket submissions | K121573 |
| Product codes | GWM |
| Device names | GWM - Device, Monitoring, Intracranial Pressure |
| Device class | Class II |
| Classification regulations (21 CFR) | 882.1620 |
| Review panels | Neurology |
| Registered establishments | Natus Medical Incorporated, Natus Neurology Incorporated |
| Establishment registrations | 2023988, 3010611950 |
| FEI numbers | 2023988, 3010611950 |
| Establishment operations | Contract Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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