The following data is part of a premarket notification filed by Oxford Medilog, Inc. with the FDA for Mentor Eeg System.
Device ID | K904763 |
510k Number | K904763 |
Device Name: | MENTOR EEG SYSTEM |
Classification | Full-montage Standard Electroencephalograph |
Applicant | OXFORD MEDILOG, INC. 11526 53RD. ST. N. Clearwater, FL 33520 |
Contact | John Gerrity |
Correspondent | John Gerrity 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 | 1990-10-22 |
Decision Date | 1991-04-10 |