MODEL 704
Device Facts
| Record ID | K912139 |
|---|---|
| Device Name | MODEL 704 |
| Applicant | Ivy Biomedical Systems, Inc. |
| Product Code | GWM · Neurology |
| Decision Date | Mar 25, 1992 |
| 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.
