ZEUS System

FDA 510(k)

FDA Class 2 ·Cardiovascular

ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAPMATE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Edwards Pressure Cable

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO XP EP NAVIGATION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

OMEGA CARES SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

ON-LINE ANALYSIS SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

4D MV-ASSESSMENT 2.0

FDA 510(k)

FDA Class 2 ·Cardiovascular

HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor

FDA 510(k)

FDA Class 2 ·Cardiovascular

EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

KODEX EPD System

FDA 510(k)

FDA Class 2 ·Cardiovascular

LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE

FDA 510(k)

FDA Class 2 ·Cardiovascular

VITALOG PMS-8 MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

RHYTHMVIEW (TM)

FDA 510(k)

FDA Class 2 ·Cardiovascular

MARS HOLTER ANALYSIS WORKSTATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

LOCALISA CARDIAC NAVIGATION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

CENTRA II ANALYSIS SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

RHYTHMIA HDx Mapping System (with software Version 2.0)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Sensis

FDA 510(k)

FDA Class 2 ·Cardiovascular

HOLTER 6000

FDA 510(k)

FDA Class 2 ·Cardiovascular