CLASS II DEVICE FOR I.C.P. MONITORING
Device Facts
| Record ID | K822636 |
|---|---|
| Device Name | CLASS II DEVICE FOR I.C.P. MONITORING |
| Applicant | Philadelphia Medical Specialties |
| Product Code | GWM · Neurology |
| Decision Date | Sep 14, 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.
