The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Tram Module.
| Device ID | K053121 |
| 510k Number | K053121 |
| Device Name: | TRAM MODULE |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | GE HEALTHCARE 86 PILGRIM ROAD Needham, MA 02492 |
| Contact | Joel Kent |
| Correspondent | Joel Kent GE HEALTHCARE 86 PILGRIM ROAD Needham, MA 02492 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-07 |
| Decision Date | 2006-04-05 |
| Summary: | summary |