The following data is part of a premarket notification filed by Oxford Medilog, Inc. with the FDA for Sleep Stager.
| Device ID | K850541 |
| 510k Number | K850541 |
| Device Name: | SLEEP STAGER |
| Classification | Non-normalizing Quantitative Electroencephalograph Software |
| Applicant | OXFORD MEDILOG, INC. 11526 53RD. ST. N. Clearwater, FL 33520 |
| Contact | John K Laurie |
| Correspondent | John K Laurie OXFORD MEDILOG, INC. 11526 53RD. ST. N. Clearwater, FL 33520 |
| Product Code | OLT |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-11 |
| Decision Date | 1985-08-02 |