The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Aware Transport Monitor System (includes Aware Pod And Aware Transport Monitor).
| Device ID | K042642 |
| 510k Number | K042642 |
| Device Name: | AWARE TRANSPORT MONITOR SYSTEM (INCLUDES AWARE POD AND AWARE TRANSPORT MONITOR) |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Andrew Kluessendorf |
| Correspondent | Andrew Kluessendorf GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-27 |
| Decision Date | 2004-11-03 |
| Summary: | summary |