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

OptiMap™ System

FDA 510(k)

FDA Class 2 ·Cardiovascular

ANALYTIC SPECTRAL METHOD OF ALTERNANS PROCESSING; CH 2000 CARDIAC DIAGNOSTIC SYSTEM; HEARTWAVE ALTERNANS PROCESSING SYS

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENDOSCOPIC INJECTION NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CARDIODAY

FDA 510(k)

FDA Class 2 ·Cardiovascular

RECORD KEEPING/DATA MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

INJECTRA INJECTION NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES

FDA 510(k)

FDA Class 2 ·Cardiovascular