INTRACRANIAL PRESSURING MONITORING SYST.
Device Facts
| Record ID | K802100 |
|---|---|
| Device Name | INTRACRANIAL PRESSURING MONITORING SYST. |
| Applicant | Pudenz-Schulte Medical Research Corp. |
| Product Code | GWM · Neurology |
| Decision Date | Sep 16, 1980 |
| 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.
