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 | K042177 |
| 510k Number | K042177 |
| Device Name: | MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM |
| Classification | Electrocardiograph |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Lisa M Baumhardt |
| Correspondent | Lisa M Baumhardt GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-11 |
| Decision Date | 2004-08-27 |
| Summary: | summary |