The following data is part of a premarket notification filed by Oxford Medilog, Inc. with the FDA for Accessory To Ecg Analysis Sys..
| Device ID | K781130 |
| 510k Number | K781130 |
| Device Name: | ACCESSORY TO ECG ANALYSIS SYS. |
| Classification | Reduced- Montage Standard Electroencephalograph |
| Applicant | OXFORD MEDILOG, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | OMC |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-07-05 |
| Decision Date | 1978-08-23 |