The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Seer Mc.
| Device ID | K042782 |
| 510k Number | K042782 |
| Device Name: | SEER MC |
| Classification | Electrocardiograph, Ambulatory, With Analysis Algorithm |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Grace Lemieux |
| Correspondent | Grace Lemieux GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Product Code | MLO |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-06 |
| Decision Date | 2005-09-02 |
| Summary: | summary |