Cleared Traditional

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

K234130 · Ge Medical Systems Information Technologies, Inc. · Anesthesiology

Mar 2024

Decision

83d

Days

Class 2

Risk

About This 510(k) Submission

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, 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 review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K234130 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	MWI — Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.2300