CARDIOSOFT/CASE CARDIAC TESTING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

HeartKey® Rhythm

FDA 510(k)

FDA Class 2 ·Cardiovascular

WINDSURFER

FDA 510(k)

FDA Class 2 ·Cardiovascular

GALIX WINTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO EP NAVIGATION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

DeepRhythmAI

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD)

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIAC ACQUISITION SYSTEM, ICR 2001

FDA 510(k)

FDA Class 2 ·Cardiovascular

DATABASE MANAGEMENT & REPORTING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENSITE SYSTEM, MODEL EE3000

FDA 510(k)

FDA Class 2 ·Cardiovascular

iMap 3D Mapping & Navigation System (iMap System)

FDA 510(k)

FDA Class 2 ·Cardiovascular

EIDOS 5003 HOLTER SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIAC DIAGNOSTIC SYSTEM MODEL CH 2000

FDA 510(k)

FDA Class 2 ·Cardiovascular

CATHEFFECTS' DESAI VECTORCATH MAPPING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

NEWCOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

SMARTFLOW

FDA 510(k)

FDA Class 2 ·Cardiovascular

PROSOLV CARDIVASCULAR VIEWER; ANALYZER; SERVER; VERSION 2.5.9

FDA 510(k)

FDA Class 2 ·Cardiovascular

BASHAW CERVICAL IMMOBILIZER DEVICE

FDA 510(k)

FDA Class 1 ·Physical Medicine

PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENSITE VELOCITY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular