The following data is part of a premarket notification filed by Nicolet Instrument Corp. with the FDA for Nicolet Ultrasom Acquisition Station.
| Device ID | K921138 |
| 510k Number | K921138 |
| Device Name: | NICOLET ULTRASOM ACQUISITION STATION |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | NICOLET INSTRUMENT CORP. 5225 VERONA RD. Madison, WI 53711 |
| Contact | Dale J Thanig |
| Correspondent | Dale J Thanig NICOLET INSTRUMENT CORP. 5225 VERONA RD. Madison, WI 53711 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-10 |
| Decision Date | 1993-05-14 |