HORIZON ANGIO CATHLAB

FDA 510(k)

FDA Class 2 ·Cardiovascular

HOLTER FOR WINDOWS

FDA 510(k)

FDA Class 2 ·Cardiovascular

DeepRhythmAI

FDA 510(k)

FDA Class 2 ·Cardiovascular

STAR Apollo™ Mapping System

FDA 510(k)

FDA Class 2 ·Cardiovascular

AcQMap High Resolution Imaging and Mapping System

FDA 510(k)

FDA Class 2 ·Cardiovascular

ST80I STRESS TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2

FDA 510(k)

FDA Class 2 ·Cardiovascular

HORIZON SE

FDA 510(k)

FDA Class 2 ·Cardiovascular

CAMBRIDGE HEART MODEL CH 2000 CARDIAC DIAGNOSTIC SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

iLab Polaris Multi-Modality Guidance System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Magnetic Localization Patch Kit (AFR-00021)

FDA 510(k)

FDA Class 2 ·Cardiovascular

LP-3000 HIGH RESOLUTION ELECTROCARDIOGRAPH

FDA 510(k)

FDA Class 2 ·Cardiovascular

RHYTHMIA HDx Mapping System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Intra-Operative Positioning System (IOPS®)

FDA 510(k)

FDA Class 2 ·Cardiovascular

NOGA CARDIAC NAVIGATION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810

FDA 510(k)

FDA Class 2 ·Cardiovascular

RHYTHM VIEW

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Spacelabs Lifescreen PRO Analyzer

FDA 510(k)

FDA Class 2 ·Cardiovascular

CHEETAH I.V.D.S., MODEL 2002P

FDA 510(k)

FDA Class 2 ·Cardiovascular