The following data is part of a premarket notification filed by Medelec Ltd. with the FDA for Dg Portable System.
| Device ID | K954157 |
| 510k Number | K954157 |
| Device Name: | DG PORTABLE SYSTEM |
| Classification | Non-normalizing Quantitative Electroencephalograph Software |
| Applicant | MEDELEC LTD. MANOR WAY Old Woking, Surrey, DE Gu22 9ju |
| Contact | Vincent Mifsud |
| Correspondent | Vincent Mifsud MEDELEC LTD. MANOR WAY Old Woking, Surrey, DE Gu22 9ju |
| Product Code | OLT |
| Subsequent Product Code | GWQ |
| Subsequent Product Code | OLV |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-05 |
| Decision Date | 1996-01-17 |