The following data is part of a premarket notification filed by Neurometrics with the FDA for Neurometrics Monitor.
| Device ID | K800452 |
| 510k Number | K800452 |
| Device Name: | NEUROMETRICS MONITOR |
| Classification | Analyzer, Spectrum, Electroencephalogram Signal |
| Applicant | NEUROMETRICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GWS |
| CFR Regulation Number | 882.1420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-02-28 |
| Decision Date | 1980-04-02 |