The following data is part of a premarket notification filed by Neurometrics with the FDA for Lifescan Eeg Monitor.
| Device ID | K841790 |
| 510k Number | K841790 |
| Device Name: | LIFESCAN EEG MONITOR |
| Classification | Non-normalizing Quantitative Electroencephalograph Software |
| Applicant | NEUROMETRICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | OLT |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-30 |
| Decision Date | 1984-07-12 |