The following data is part of a premarket notification filed by Nicolet Instrument Corp. with the FDA for Nicolet Nystar Plus System.
| Device ID | K884294 |
| 510k Number | K884294 |
| Device Name: | NICOLET NYSTAR PLUS SYSTEM |
| Classification | Nystagmograph |
| Applicant | NICOLET INSTRUMENT CORP. 5225 VERONA RD. Madison, WI 53711 |
| Contact | Raymond T Riddle |
| Correspondent | Raymond T Riddle NICOLET INSTRUMENT CORP. 5225 VERONA RD. 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 | 1988-10-12 |
| Decision Date | 1988-11-23 |