The following data is part of a premarket notification filed by Nxlink, Ltd. with the FDA for Neurometric Analysis System.
| Device ID | K974748 |
| 510k Number | K974748 |
| Device Name: | NEUROMETRIC ANALYSIS SYSTEM |
| Classification | Normalizing Quantitative Electroencephalograph Software |
| Applicant | NXLINK, LTD. 1706 GAILLARD PL. Richland, WA 99352 -2624 |
| Contact | Duane Shuttlesworth |
| Correspondent | Duane Shuttlesworth NXLINK, LTD. 1706 GAILLARD PL. Richland, WA 99352 -2624 |
| Product Code | OLU |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-19 |
| Decision Date | 1998-07-10 |
| Summary: | summary |