COMAN(R) CU-11 MODEL NUMBER 82-6634
Device Facts
| Record ID | K945585 |
|---|---|
| Device Name | COMAN(R) CU-11 MODEL NUMBER 82-6634 |
| Applicant | Johnson & Johnson Professionals, Inc. |
| Product Code | GWM · Neurology |
| Decision Date | Oct 26, 1995 |
| 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.
