The following data is part of a premarket notification filed by General Electric Medical Systems Information Techn with the FDA for Mac-lab System And Cardiolab Ep System.
| Device ID | K001305 |
| 510k Number | K001305 |
| Device Name: | MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN 13000 EXECUTIVE DR. Sugarland, TX 77478 |
| Contact | J. Lan Mcdonald |
| Correspondent | J. Lan Mcdonald GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN 13000 EXECUTIVE DR. Sugarland, TX 77478 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-24 |
| Decision Date | 2000-06-27 |