The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Mac-lab/cardiolab /combolab/specialslab System.
| Device ID | K061741 |
| 510k Number | K061741 |
| Device Name: | MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | GE HEALTHCARE 9900 W INNOVATION DRIVE Wauwatosa, WI 53226 |
| Contact | Allen Tabor |
| Correspondent | Allen Tabor GE HEALTHCARE 9900 W INNOVATION DRIVE Wauwatosa, WI 53226 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-20 |
| Decision Date | 2006-09-15 |
| Summary: | summary |