The following data is part of a premarket notification filed by Nicolet Instrument Corp. with the FDA for Nicolet Mapleleaf System.
| Device ID | K905632 |
| 510k Number | K905632 |
| Device Name: | NICOLET MAPLELEAF SYSTEM |
| Classification | Stimulator, Auditory, Evoked Response |
| Applicant | NICOLET INSTRUMENT CORP. 5225 VERONA RD. Madison, WI 53711 |
| Contact | Raymond Riddle |
| Correspondent | Raymond Riddle NICOLET INSTRUMENT CORP. 5225 VERONA RD. Madison, WI 53711 |
| Product Code | GWJ |
| CFR Regulation Number | 882.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-17 |
| Decision Date | 1991-06-07 |