OPX-VX FEBEROPTIC INTRACRANIAL PRESSURE MONITORING CATHETER WITH DRAINAGE
Device Facts
| Record ID | K943987 |
|---|---|
| Device Name | OPX-VX FEBEROPTIC INTRACRANIAL PRESSURE MONITORING CATHETER WITH DRAINAGE |
| Applicant | Innerspace Medical, Inc. |
| Product Code | GWM · Neurology |
| Decision Date | Dec 7, 1994 |
| 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.
