The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Modification To Unity Network Id.
| Device ID | K040559 |
| 510k Number | K040559 |
| Device Name: | MODIFICATION TO UNITY NETWORK ID |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Diana M Thorson |
| Correspondent | Diana M Thorson GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-03 |
| Decision Date | 2004-06-04 |
| Summary: | summary |