K234130
- 510(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. WI · US
- Product code
- MWI — Monitor, Physiological, Patient (Without Arrhythmia
- Decision date
- 2024-03-20
- Date received
- 2023-12-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K234130.pdf
Official FDA record: K234130
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.