The following data is part of a premarket notification filed by Oxford Medilog, Inc. with the FDA for Model 9000 Recording & Electrophysiological System.
| Device ID | K860456 |
| 510k Number | K860456 |
| Device Name: | MODEL 9000 RECORDING & ELECTROPHYSIOLOGICAL SYSTEM |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | OXFORD MEDILOG, INC. 11526 53RD. ST. N. Clearwater, FL 33520 |
| Contact | Alan P Schwartz |
| Correspondent | Alan P Schwartz OXFORD MEDILOG, INC. 11526 53RD. ST. N. Clearwater, FL 33520 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-05 |
| Decision Date | 1986-08-11 |