The following data is part of a premarket notification filed by Nicolet Biomedical Instruments with the FDA for Pathfinder Electrodiagnostic System.
| Device ID | K801604 |
| 510k Number | K801604 |
| Device Name: | PATHFINDER ELECTRODIAGNOSTIC SYSTEM |
| Classification | Conditioner, Signal, Physiological |
| Applicant | NICOLET BIOMEDICAL INSTRUMENTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GWK |
| CFR Regulation Number | 882.1845 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-14 |
| Decision Date | 1980-08-04 |