The following data is part of a premarket notification filed by Nicolet Biomedical Instruments with the FDA for Tm-5 Intracranial Pressure Monitor.
| Device ID | K802149 |
| 510k Number | K802149 |
| Device Name: | TM-5 INTRACRANIAL PRESSURE MONITOR |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | NICOLET BIOMEDICAL INSTRUMENTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-08 |
| Decision Date | 1980-11-12 |