The following data is part of a premarket notification filed by Medelec Ltd. with the FDA for Dg Nervus.
| Device ID | K964280 |
| 510k Number | K964280 |
| Device Name: | DG NERVUS |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | MEDELEC LTD. MANOR WAY Old Woking, Surrey, DE Gu22 9ju |
| Contact | Carol Bleakley |
| Correspondent | Carol Bleakley MEDELEC LTD. MANOR WAY Old Woking, Surrey, DE Gu22 9ju |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-28 |
| Decision Date | 1997-01-27 |