The following data is part of a premarket notification filed by Medelec Ltd. with the FDA for Dg 3p System.
| Device ID | K934670 |
| 510k Number | K934670 |
| Device Name: | DG 3P SYSTEM |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | MEDELEC LTD. MANOR WAY Old Woking, Surrey, DE Gu22 9ju |
| Contact | J B Halloway |
| Correspondent | J B Halloway 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 | 1993-09-29 |
| Decision Date | 1994-05-25 |