21 CFR 882.1620 — Device, Monitoring, Intracranial Pressure
Neurology (NE) · Part 882 Subpart B—Neurological Diagnostic Devices · § 882.1620
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).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GWM | Device, Monitoring, Intracranial Pressure | 2 | 105 | 3rd Party |
| PSP | Intracranial Pressure & Temperature Monitoring Kit | 2 | 0 |
