The following data is part of a premarket notification filed by General Electric Medical Systems Information Techn with the FDA for Mac 5000 Ecg Analysis System.
| Device ID | K014108 |
| 510k Number | K014108 |
| Device Name: | MAC 5000 ECG ANALYSIS SYSTEM |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Lisa Lee Michels |
| Correspondent | Lisa Lee Michels GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-13 |
| Decision Date | 2002-01-10 |
| Summary: | summary |