The following data is part of a premarket notification filed by General Electric Medical Systems Information Techn with the FDA for Ge Marquette Medical Systems Prucka Cardiolab Cath System, Version 1.11.
| Device ID | K000645 |
| 510k Number | K000645 |
| Device Name: | GE MARQUETTE MEDICAL SYSTEMS PRUCKA CARDIOLAB CATH SYSTEM, VERSION 1.11 |
| Classification | Electrocardiograph |
| Applicant | GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN 13000 EXECUTIVE DR. Sugarland, TX 77478 |
| Contact | Ian Mcdonald |
| Correspondent | Ian Mcdonald GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN 13000 EXECUTIVE DR. Sugarland, TX 77478 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-25 |
| Decision Date | 2000-05-24 |