Ge Medical Systems Information Technologies, Inc. · Class II · Cleared Aug 11, 2023
| K-number | K230626 |
| Device name | Portrait Central Viewer Application (Portrait CV A01), Portrait Core Services (Portrait CSS01), Portrait Clinical Alarming Unit (Portrait CAU01); Portrait Mobile Patient Monitor (Portrait HUB01), Portrait Sensor Battery (Portrait SBT01), Portrait Bedside Charger (Portrait BCH01); Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait SpO2 P-SE01); Portrait SpO2 Attachment Accessory Band (Portrait AAB01), Portrait |
| Applicant | Ge Medical Systems Information Technologies, Inc. |
| Product code | MWI |
| Device class | Class II |
| Decision date | Aug 11, 2023 |
| Decision | Substantially Equivalent |
| Regulation | 870.2300 |
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