HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart Recovery); HemoSphere Alta™ Advanced Monitor (Cardiac); HemoSphere Alta™ Advanced Monitor (All-on-One)

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Cardiovascular

EP-WORKMATE SYSTEM, VERSION 4.2

FDA 510(k)

FDA Class 2 ·Cardiovascular

EnSite™ X EP System

FDA 510(k)

FDA Class 2 ·Cardiovascular

QUANTIEN Measurement System

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

INTELLISPACE ECG

FDA 510(k)

FDA Class 2 ·Cardiovascular

PC HOLTER SCANNING SYSTEM SIMPLICITY, ALTAIR 8200, 8300, 8400

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPACELABS SMART DISCLOSURE SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

AcQMap High Resolution Imaging and Mapping System

FDA 510(k)

FDA Class 2 ·Cardiovascular

T-WAVE ALTERMANS (TWA) ALGORITHM OPTION

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

CER-S

FDA 510(k)

FDA Class 2 ·Cardiovascular

SENSIS, SENSIS LITE

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENDO PAT 2000

FDA 510(k)

FDA Class 2 ·Cardiovascular

RESPIEVENTS

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO 3 EP Navigation System, Version 7.1 and Accessories

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLINICAL GRAPHICS ANALYZER

FDA 510(k)

FDA Class 2 ·Cardiovascular