PSP · Intracranial Pressure & Temperature Monitoring Kit
Neurology · 21 CFR 882.1620 · Class 2
Overview
| Product Code | PSP |
|---|---|
| Device Name | Intracranial Pressure & Temperature Monitoring Kit |
| Regulation | 21 CFR 882.1620 |
| Device Class | Class 2 |
| Review Panel | Neurology |
Identification
An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
