The following data is part of a premarket notification filed by Oxford Medilog, Inc. with the FDA for Medilog Excel Ecg Analysis System (modified).
| Device ID | K920295 |
| 510k Number | K920295 |
| Device Name: | MEDILOG EXCEL ECG ANALYSIS SYSTEM (MODIFIED) |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | OXFORD MEDILOG, INC. 11526 53RD. ST. N. Clearwater, FL 33520 |
| Contact | Charles Holz |
| Correspondent | Charles Holz OXFORD MEDILOG, INC. 11526 53RD. ST. N. Clearwater, FL 33520 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-22 |
| Decision Date | 1992-08-18 |