The following data is part of a premarket notification filed by Ge Medical Syst. Information Technologies with the FDA for Heart Rate Turbulence Analysis Technologies.
| Device ID | K042148 |
| 510k Number | K042148 |
| Device Name: | HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | GE MEDICAL SYST. INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Lisa M Baumhardt |
| Correspondent | Lisa M Baumhardt GE MEDICAL SYST. 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 | 2004-08-09 |
| Decision Date | 2004-12-03 |
| Summary: | summary |