The following data is part of a premarket notification filed by General Electric Medical Systems Information Techn with the FDA for Tram 2001 Module.
| Device ID | K011000 |
| 510k Number | K011000 |
| Device Name: | TRAM 2001 MODULE |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Karen Webb |
| Correspondent | Karen Webb GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN 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 | 2001-04-03 |
| Decision Date | 2001-06-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682103008 | K011000 | 000 |