The following data is part of a premarket notification filed by Neurometrics with the FDA for Lifescan Evoked Potential System.
| Device ID | K861900 |
| 510k Number | K861900 |
| Device Name: | LIFESCAN EVOKED POTENTIAL SYSTEM |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | NEUROMETRICS 5720 OBERLIN DR. San Diego, CA 92121 |
| Contact | Paul Verduchi |
| Correspondent | Paul Verduchi NEUROMETRICS 5720 OBERLIN DR. San Diego, CA 92121 |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-16 |
| Decision Date | 1986-08-25 |