K234130 is an FDA 510(k) clearance for the 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. This device is classified as a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II - Special Controls, product code MWI).
Submitted by Ge Medical Systems Information Technologies, Inc. (Wauwatosa, US). The FDA issued a Cleared decision on March 20, 2024, 83 days after receiving the submission on December 28, 2023.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2300.
| 510(k) Number | K234130 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 28, 2023 |
| Decision Date | March 20, 2024 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | MWI — Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2300 |