The following data is part of a premarket notification filed by Oxford Medilog, Inc. with the FDA for Medilog 9000 System.
Device ID | K830295 |
510k Number | K830295 |
Device Name: | MEDILOG 9000 SYSTEM |
Classification | Full-montage Standard Electroencephalograph |
Applicant | OXFORD MEDILOG, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GWQ |
CFR Regulation Number | 882.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-01-27 |
Decision Date | 1983-03-24 |