RHYTHMIA HDx™ Mapping System

FDA 510(k)

FDA Class 2 ·Cardiovascular

ASTRONOMER PLUS SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

INNOCOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

VX1+

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAC 5000 ECG ANALYSIS SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

AMBULATORY (HOLTER) RECORDING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)

FDA 510(k)

FDA Class 2 ·Cardiovascular

AcQMap High Resolution Imaging and Mapping System

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIO SPECTRUM DIAGNOSTIC SYSTEM (CSD)

FDA 510(k)

FDA Class 2 ·Cardiovascular

CATHWRITER(TM)

FDA 510(k)

FDA Class 2 ·Cardiovascular

MUSE CARDIOLOGY INFORMATION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO XP EP NAVIGATION SYSTEM, SOFTWARE VERISON 8

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEAD-IMMOBILIZER

FDA 510(k)

FDA Class 1 ·Physical Medicine

HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform

FDA 510(k)

FDA Class 2 ·Cardiovascular

QUANTIEN MEASUREMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEWLETT PACKARD MODEL 5650C, CARDIO DATA MGMT SYST

FDA 510(k)

FDA Class 2 ·Cardiovascular

Zio XT ECG Monitoring System, Zio AT ECG Monitoring System

FDA 510(k)

FDA Class 2 ·Cardiovascular

KODEX – EPD™ System 1.5.0

FDA 510(k)

FDA Class 2 ·Cardiovascular

THE OPHTHIMUS SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular