The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Ek-pro Arrhythmia Detection Algorithm.
| Device ID | K031320 |
| 510k Number | K031320 |
| Device Name: | EK-PRO ARRHYTHMIA DETECTION ALGORITHM |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Karen M Lunde |
| Correspondent | Karen M Lunde GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-25 |
| Decision Date | 2003-05-06 |
| Summary: | summary |