The following data is part of a premarket notification filed by Nicolet Biomedical Instruments with the FDA for Vts-1000 Visual Testing System.
| Device ID | K812331 |
| 510k Number | K812331 |
| Device Name: | VTS-1000 VISUAL TESTING SYSTEM |
| Classification | Photostimulator, Ac-powered |
| Applicant | NICOLET BIOMEDICAL INSTRUMENTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HLX |
| CFR Regulation Number | 886.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-18 |
| Decision Date | 1981-11-16 |