The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Intracranial Pressure Monitoring Device.
| Device ID | K822864 |
| 510k Number | K822864 |
| Device Name: | INTRACRANIAL PRESSURE MONITORING DEVICE |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | MEDEX, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-27 |
| Decision Date | 1982-11-16 |