DATACAPTOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Masimo Rad-97 and Accessories

FDA 510(k)

FDA Class 2 ·Cardiovascular

ViSi Mobile Monitoring System

FDA 510(k)

FDA Class 2 ·Cardiovascular

AcQMap® High Resolution Imaging and Mapping System

FDA 510(k)

FDA Class 2 ·Cardiovascular

WorkMate Claris System, WorkMate Claris System Display Plus

FDA 510(k)

FDA Class 2 ·Cardiovascular

VECTOR EVENT GRID ARCHITECTURE (VEGA) SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

DATEX-OHMEDA S/5 CARDIAC OUTPUT AND SVO2 MODULE, E-COPSV AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Cardiovascular

AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub

FDA 510(k)

FDA Class 2 ·Cardiovascular

STAR 65

FDA 510(k)

FDA Class 2 ·Cardiovascular

RADIANALYZER XPRESS

FDA 510(k)

FDA Class 2 ·Cardiovascular

STRESSWRITER EXERCISE TESTING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIOSIGN CENTRAL STATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Graffiti

FDA 510(k)

FDA Class 2 ·Cardiovascular

Rhythm View Workstation (non-streaming, steaming option)

FDA 510(k)

FDA Class 2 ·Cardiovascular

DECISIO HEALTH PATIENT DASHBOARD

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories

FDA 510(k)

FDA Class 2 ·Cardiovascular

OMRON MODEL HBP-2070 VITAL SIGNS MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Cardiovascular