DYE CURVE EVALUATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO: RADIANALYZER, MODEL 12711

FDA 510(k)

FDA Class 2 ·Cardiovascular

SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

STAR (LUNAR SERIES) MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

VITAL SYNC MODEL 5000 SERIES

FDA 510(k)

FDA Class 2 ·Cardiovascular

HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI)

FDA 510(k)

FDA Class 2 ·Cardiovascular

PC ECG 1200W SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Change Healthcare Cardiology Hemodynamics™

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION OF NOGA

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIOSOFT/CASE CARDIAC TESTING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

HeartKey® Rhythm

FDA 510(k)

FDA Class 2 ·Cardiovascular

WINDSURFER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CONNEX VITAL SIGNS MONITOR 6000 SERIES

FDA 510(k)

FDA Class 2 ·Cardiovascular

GALIX WINTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO EP NAVIGATION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

OMNI PATIENT MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

DeepRhythmAI

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD)

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIAC ACQUISITION SYSTEM, ICR 2001

FDA 510(k)

FDA Class 2 ·Cardiovascular

MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160

FDA 510(k)

FDA Class 2 ·Cardiovascular