The following data is part of a premarket notification filed by Nicolet Biomedical Instruments with the FDA for Brain Function Mapping Option For Pathf.
| Device ID | K843598 |
| 510k Number | K843598 |
| Device Name: | BRAIN FUNCTION MAPPING OPTION FOR PATHF |
| Classification | Conditioner, Signal, Physiological |
| Applicant | NICOLET BIOMEDICAL INSTRUMENTS P.O. BOX 4287 Madison , WI 53711 - |
| Contact | Ron Luich |
| Correspondent | Ron Luich NICOLET BIOMEDICAL INSTRUMENTS P.O. BOX 4287 Madison , WI 53711 - |
| Product Code | GWK |
| CFR Regulation Number | 882.1845 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-12 |
| Decision Date | 1985-04-11 |