The following data is part of a premarket notification filed by Nicolet Biomedical Instruments with the FDA for Stimulator, Nic-106 Visual.
| Device ID | K790570 |
| 510k Number | K790570 |
| Device Name: | STIMULATOR, NIC-106 VISUAL |
| Classification | Stimulator, Photic, Evoked Response |
| Applicant | NICOLET BIOMEDICAL INSTRUMENTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GWE |
| CFR Regulation Number | 882.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-03-23 |
| Decision Date | 1979-05-23 |