The following data is part of a premarket notification filed by Nicolet Biomedical Instruments with the FDA for Nystagmograph Eog/eng Analyses.
| Device ID | K851190 |
| 510k Number | K851190 |
| Device Name: | NYSTAGMOGRAPH EOG/ENG ANALYSES |
| Classification | Nystagmograph |
| Applicant | NICOLET BIOMEDICAL INSTRUMENTS 5225-4 VERONA RD. P.O. BOX 4287 Madison, WI 53711 |
| Contact | Ron Luich |
| Correspondent | Ron Luich NICOLET BIOMEDICAL INSTRUMENTS 5225-4 VERONA RD. P.O. BOX 4287 Madison, WI 53711 |
| Product Code | GWN |
| CFR Regulation Number | 882.1460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-26 |
| Decision Date | 1985-11-27 |