The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Mac-lab System, Cardiolab System, Combolab System, Specialslab System.
| Device ID | K111200 |
| 510k Number | K111200 |
| Device Name: | MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEM |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | GE HEALTHCARE 8200 WEST TOWER AVE Milwaukee, WI 53223 |
| Contact | Carol Alloian |
| Correspondent | Carol Alloian GE HEALTHCARE 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 | 2011-04-29 |
| Decision Date | 2011-10-12 |
| Summary: | summary |