ENSITE VELOCITY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

SCHUL-TEC IMMOBILIZER

FDA 510(k)

FDA Class 1 ·Physical Medicine

CARDIAC PERFORMANCE MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

RADIANALYZER, MODEL 12710

FDA 510(k)

FDA Class 2 ·Cardiovascular

ASTRONOMER+WITH SLD

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAC-LAB/CARDIOLAB EP/COMBOLAB

FDA 510(k)

FDA Class 2 ·Cardiovascular

Zio AT ECG Monitoring System, ZEUS System

FDA 510(k)

FDA Class 2 ·Cardiovascular

EnSite™ X EP System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ultiri Measurement System

FDA 510(k)

FDA Class 2 ·Cardiovascular

HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, Acumen Assisted Fluid Management Feature, Viewfinder Remote

FDA 510(k)

FDA Class 2 ·Cardiovascular

ECVUE MAPPING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

iLab Polaris Multi-Modality Guidance System

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005

FDA 510(k)

FDA Class 2 ·Cardiovascular

INFINITY MEGACARE

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENSITE VELOCITY SYSTEM, MODEL EE3000

FDA 510(k)

FDA Class 2 ·Cardiovascular

EP-WORKMATE

FDA 510(k)

FDA Class 2 ·Cardiovascular

RhythmView Workstation

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO RMT EP NAVIGATION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

RHYTHMSCAN PRECISION 6000

FDA 510(k)

FDA Class 2 ·Cardiovascular