The following data is part of a premarket notification filed by Oxford Instruments, Plc. with the FDA for Medilog Mr95.
| Device ID | K961642 |
| 510k Number | K961642 |
| Device Name: | MEDILOG MR95 |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | OXFORD INSTRUMENTS, PLC. 11526 53RD ST. N. Clearwater, FL 34620 |
| Contact | Charles Holz |
| Correspondent | Charles Holz OXFORD INSTRUMENTS, PLC. 11526 53RD ST. N. Clearwater, FL 34620 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-29 |
| Decision Date | 1997-01-17 |