The following data is part of a premarket notification filed by General Electric Medical Systems Information Techn with the FDA for Ge Marquette Ecg Analysis Program.
| Device ID | K002209 |
| 510k Number | K002209 |
| Device Name: | GE MARQUETTE ECG ANALYSIS PROGRAM |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Kristin Pabst |
| Correspondent | Kristin Pabst GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN 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 | 2000-07-21 |
| Decision Date | 2000-08-18 |