INTRACRANIAL PRESSURE MONITORING DEVICE
Device Facts
| Record ID | K822864 |
|---|---|
| Device Name | INTRACRANIAL PRESSURE MONITORING DEVICE |
| Applicant | Medex, Inc. |
| Product Code | GWM · Neurology |
| Decision Date | Nov 16, 1982 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1620 |
| Device Class | Class 2 |
Regulatory Classification
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.