The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Transtar Intracranial Pressure Transducer, Model Mx950icp.
| Device ID | K020780 |
| 510k Number | K020780 |
| Device Name: | TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | MEDEX, INC. 6250 SHIER RINGS RD. Dublin, OH 43016 |
| Contact | Barbara Law |
| Correspondent | Barbara Law MEDEX, INC. 6250 SHIER RINGS RD. Dublin, OH 43016 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-11 |
| Decision Date | 2002-05-20 |