The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Mac-lab/cardiolab Ep/combolab System.
| Device ID | K050093 |
| 510k Number | K050093 |
| Device Name: | MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Ronald N Blaski |
| Correspondent | Ronald N Blaski GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-14 |
| Decision Date | 2005-05-13 |
| Summary: | summary |