The following data is part of a premarket notification filed by Nicolet Instrument Corp. with the FDA for Nicolet Beam Ii System.
| Device ID | K894629 |
| 510k Number | K894629 |
| Device Name: | NICOLET BEAM II SYSTEM |
| Classification | Analyzer, Spectrum, Electroencephalogram Signal |
| Applicant | NICOLET INSTRUMENT CORP. 5225 VERONA RD. Madison, WI 53711 |
| Contact | T Riddle |
| Correspondent | T Riddle NICOLET INSTRUMENT CORP. 5225 VERONA RD. Madison, WI 53711 |
| Product Code | GWS |
| CFR Regulation Number | 882.1420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-24 |
| Decision Date | 1990-03-09 |