The following data is part of a premarket notification filed by Nicolet Instrument Corp. with the FDA for Nicolet Poratble Spirit System.
| Device ID | K915652 |
| 510k Number | K915652 |
| Device Name: | NICOLET PORATBLE SPIRIT SYSTEM |
| Classification | Stimulator, Electrical, Evoked Response |
| 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 | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-18 |
| Decision Date | 1992-02-07 |