The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Unity Network Is Patient Viewer.
| Device ID | K032346 |
| 510k Number | K032346 |
| Device Name: | UNITY NETWORK IS PATIENT VIEWER |
| Classification | System, Network And Communication, Physiological Monitors |
| 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 | MSX |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-30 |
| Decision Date | 2003-08-05 |
| Summary: | summary |