The following data is part of a premarket notification filed by Nicolet Biomedical Instruments with the FDA for Nicolet Expert Sleep/wake Analysis System.
| Device ID | K873535 |
| 510k Number | K873535 |
| Device Name: | NICOLET EXPERT SLEEP/WAKE ANALYSIS SYSTEM |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | NICOLET BIOMEDICAL INSTRUMENTS 5225-4 VERONA RD. P.O. BOX 4287 Madison, WI 53711 |
| Contact | Raymond T Riddle |
| Correspondent | Raymond T Riddle NICOLET BIOMEDICAL INSTRUMENTS 5225-4 VERONA RD. P.O. BOX 4287 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 | 1987-09-01 |
| Decision Date | 1987-10-26 |