Ge Medical Systems Information Technologies, Inc. · Class II · Cleared Mar 20, 2024
| K-number | K234130 |
| Device name | Portrait Mobile Monitoring Solution consists of: Portrait Central Viewer Application (Portrait CVAXB) Portrait Core Services (Portrait CSSXB) Portrait Clinical Alarming Unit (Portrait CAU01) Portrait Mobile Patient Monitor Hardware (Portrait HUBXB) Portrait Mobile Patient Monitor Software (Portrait HSWXB) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) Portrait Wearable Pulse O |
| Applicant | Ge Medical Systems Information Technologies, Inc. |
| Product code | MWI |
| Device class | Class II |
| Decision date | Mar 20, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 870.2300 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov