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 |