The following data is part of a premarket notification filed by Medelec Intl. Corp. with the FDA for Electroencephalograph Recording System.
| Device ID | K920127 |
| 510k Number | K920127 |
| Device Name: | ELECTROENCEPHALOGRAPH RECORDING SYSTEM |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | MEDELEC INTL. CORP. MANOR WAY OLD WOKING, SURREY GU22 9JU England, GB |
| Contact | Holloway |
| Correspondent | Holloway MEDELEC INTL. CORP. MANOR WAY OLD WOKING, SURREY GU22 9JU England, GB |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-10 |
| Decision Date | 1992-06-10 |