The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Modification To Mac 5000 Ecg Analysis System.
| Device ID | K033492 |
| 510k Number | K033492 |
| Device Name: | MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Lisa Lee Michels |
| Correspondent | Lisa Lee Michels 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 | 2003-11-04 |
| Decision Date | 2003-11-24 |
| Summary: | summary |