The following data is part of a premarket notification filed by Lexicor Medical Technology, Inc. with the FDA for Neurosearch-24 Or Nrs-24.
| Device ID | K915820 |
| 510k Number | K915820 |
| Device Name: | NEUROSEARCH-24 OR NRS-24 |
| Classification | Non-normalizing Quantitative Electroencephalograph Software |
| Applicant | LEXICOR MEDICAL TECHNOLOGY, INC. 2585 CENTRAL AVE. Boulder, CO 80301 |
| Contact | Kenneth D Nichols |
| Correspondent | Kenneth D Nichols LEXICOR MEDICAL TECHNOLOGY, INC. 2585 CENTRAL AVE. Boulder, CO 80301 |
| Product Code | OLT |
| Subsequent Product Code | GWQ |
| Subsequent Product Code | HCC |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-30 |
| Decision Date | 1995-02-08 |