The following data is part of a premarket notification filed by Nicolet Biomedical Instruments with the FDA for Nic Optronics Cs-2000.
| Device ID | K822215 |
| 510k Number | K822215 |
| Device Name: | NIC OPTRONICS CS-2000 |
| Classification | Chart, Visual Acuity |
| Applicant | NICOLET BIOMEDICAL INSTRUMENTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HOX |
| CFR Regulation Number | 886.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-26 |
| Decision Date | 1982-08-31 |