ENSITE 3000 SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

NeuTrace EP Mapping System v.2.1

FDA 510(k)

FDA Class 2 ·Cardiovascular

EP-WORKMATE

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPACELABS-GENERAL SYSTEM LINK

FDA 510(k)

FDA Class 2 ·Cardiovascular

FusedCO Algorithm

FDA 510(k)

FDA Class 2 ·Cardiovascular

PDS CARDIAC CALC. SOFTW. PROGR. #A3604AE

FDA 510(k)

FDA Class 2 ·Cardiovascular

AcQMap High Resolution Imaging and Mapping System

FDA 510(k)

FDA Class 2 ·Cardiovascular

LIFESHIRT REAL-TIME WITH VIVOMONITOR SOFTWARE

FDA 510(k)

FDA Class 2 ·Cardiovascular

RESPIEVENTS SOFTWARE IS EVENT DATA PROCESSING SOFWARE FOR A PC

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ablamap Software

FDA 510(k)

FDA Class 2 ·Cardiovascular

HemoSphere Advanced Monitor, HemoSphere Pressure Cable

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL REFERENCE PATCHES (MODEL:D-1283-01)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENSITE 3000 SYSTEM, MODEL EE3000

FDA 510(k)

FDA Class 2 ·Cardiovascular

ECGenius System

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO XP EP NAVIGATION SYSTEM, VERSION 9

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module

FDA 510(k)

FDA Class 2 ·Cardiovascular

Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1)

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIOSERVER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO 3 EP Navigation System Version 7.2

FDA 510(k)

FDA Class 2 ·Cardiovascular