The following data is part of a premarket notification filed by Oxford Medilog, Inc. with the FDA for Medilog 9200 Eeg Replay/analysis System.
Device ID | K891383 |
510k Number | K891383 |
Device Name: | MEDILOG 9200 EEG REPLAY/ANALYSIS SYSTEM |
Classification | Automatic Event Detection Software For Polysomnograph With Electroencephalograph |
Applicant | OXFORD MEDILOG, INC. 11526 53RD. ST. N. Clearwater, FL 33520 |
Contact | Michael J Smith |
Correspondent | Michael J Smith OXFORD MEDILOG, INC. 11526 53RD. ST. N. Clearwater, FL 33520 |
Product Code | OLZ |
CFR Regulation Number | 882.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-03-09 |
Decision Date | 1989-06-01 |