
Ge Medical Systems Information Technologies, Inc.
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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 is an FDA 510(k)-cleared medical device (K234130) manufactured by Ge Medical Systems Information Technologies, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 19, 2024. Regulation: 8.

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