The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Mactrode 3.
| Device ID | K060661 |
| 510k Number | K060661 |
| Device Name: | MACTRODE 3 |
| Classification | Electrode, Electrocardiograph |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Karen Russell |
| Correspondent | Karen Russell GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-13 |
| Decision Date | 2006-04-07 |
| Summary: | summary |