The following data is part of a premarket notification filed by General Electric Medical Systems Information Techn with the FDA for Unity Is Patient Viewer.
| Device ID | K020661 |
| 510k Number | K020661 |
| Device Name: | UNITY IS PATIENT VIEWER |
| Classification | System, Network And Communication, Physiological Monitors |
| 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 | MSX |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-01 |
| Decision Date | 2002-05-24 |
| Summary: | summary |