The following data is part of a premarket notification filed by Oxford Medilog, Inc. with the FDA for Model 5000 Ambulatory Monitoring System.
Device ID | K871500 |
510k Number | K871500 |
Device Name: | MODEL 5000 AMBULATORY MONITORING SYSTEM |
Classification | Full-montage Standard 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 | GWQ |
CFR Regulation Number | 882.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-16 |
Decision Date | 1987-07-01 |