Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Unity Network ID

FDA 510(k)

FDA Class 2 ·Cardiovascular

AcQMap High Resolution Imaging and Mapping System

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIO SPECTRUM DIAGNOSTIC SYSTEM (CSD)

FDA 510(k)

FDA Class 2 ·Cardiovascular

COMEN MULTI-PARAMETER PATIENT MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Talis EMR with Talis +ACG (Talis EMR with +ACG)

FDA 510(k)

FDA Class 2 ·Cardiovascular

UNITY NETWORK ID

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO PM-8000 PATIENT MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

RVS-100 Vital Signs Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO: UNITY NETWORK ID

FDA 510(k)

FDA Class 2 ·Cardiovascular

740 SELECT

FDA 510(k)

FDA Class 2 ·Cardiovascular

CATHWRITER(TM)

FDA 510(k)

FDA Class 2 ·Cardiovascular

MUSE CARDIOLOGY INFORMATION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

8100/8500 VITAL SIGNS MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX

FDA 510(k)

FDA Class 2 ·Cardiovascular

Oxi-W System

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO XP EP NAVIGATION SYSTEM, SOFTWARE VERISON 8

FDA 510(k)

FDA Class 2 ·Cardiovascular

SKYLINE 55

FDA 510(k)

FDA Class 2 ·Cardiovascular

OMNI II PATIENT MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

NIGHTINGALE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular