BEDSIDE PAEDIATRIC EARLY WARNING SYSTEM (BEDSIDEPEWS)

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLEO PATIENT MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM

FDA 510(k)

FDA Class 2 ·Cardiovascular

B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared Radiation Energy Technology(IRT) Thermometer probe, B.O.L.T Pulse Oximeter(SPO2) probe, B.O.L.T Gluchobin Blood Glucose, Total Cholesterol and Hemoglobin meter

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARESCAPE MODEL V100 VITAL SIGNS MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

CENTRA VIEW DEVICE LINK SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

MRI Patient Monitor TeslaDUO

FDA 510(k)

FDA Class 2 ·Cardiovascular

NeoBeat, NeoBeat Mini

FDA 510(k)

FDA Class 2 ·Cardiovascular

VC150 VITAL SIGNS MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

PeraMobile and PeraWatch

FDA 510(k)

FDA Class 2 ·Cardiovascular

HP M2376A DEVICE LINK SYSTEM, MODEL M2376A

FDA 510(k)

FDA Class 2 ·Cardiovascular

TESLAGUARD, MODEL EFT G04

FDA 510(k)

FDA Class 2 ·Cardiovascular

NEXAN SYSTEM, MODEL NX-301

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

FDA 510(k)

FDA Class 2 ·Cardiovascular

Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIONET BM3PLUS PATIENT MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

ZOLL Propaq M

FDA 510(k)

FDA Class 2 ·Cardiovascular

VISI MOBILE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Vital Sync Informatics Manager & Virtual Patient Monitoring Platform

FDA 510(k)

FDA Class 2 ·Cardiovascular

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™

FDA 510(k)

FDA Class 2 ·Cardiovascular