The following data is part of a premarket notification filed by Nicolet Biomedical Instruments with the FDA for Nicolet Amp 6r11 System.
| Device ID | K871678 |
| 510k Number | K871678 |
| Device Name: | NICOLET AMP 6R11 SYSTEM |
| Classification | Amplifier, Physiological Signal |
| Applicant | NICOLET BIOMEDICAL INSTRUMENTS 5225-4 VERONA RD. P.O. BOX 4287 Madison, WI 53711 |
| Contact | Luich, Pe |
| Correspondent | Luich, Pe NICOLET BIOMEDICAL INSTRUMENTS 5225-4 VERONA RD. P.O. BOX 4287 Madison, WI 53711 |
| Product Code | GWL |
| CFR Regulation Number | 882.1835 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-28 |
| Decision Date | 1987-07-16 |