QUINTON Q-CATH, MODEL 000460

FDA 510(k)

FDA Class 2 ·Cardiovascular

NOVA PILLOW

FDA 510(k)

FDA Class 1 ·Physical Medicine

PHYSIOLOG, SERIES 95000

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO: MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

QUANTIEN Measurement System

FDA 510(k)

FDA Class 2 ·Cardiovascular

VIVO

FDA 510(k)

FDA Class 2 ·Cardiovascular

EnSite X EP System

FDA 510(k)

FDA Class 2 ·Cardiovascular

AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Merge Hemo

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO: ENSITE SYSTEM, MODEL, EE3000

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDIGUIDE TECHNOLOGY

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAC

FDA UDI

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.·00840682134859·

CAM

FDA UDI

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.·00840682112406·

LIFECARD CF and PATHFINDER SL

FDA UDI

SPACELABS HEALTHCARE (WASHINGTON), INC·10841522127212·PACKAGE, LIFECARD CF AND PATHFINDER SL

AcQMap

FDA UDI

ACUTUS MEDICAL, INC.·00850027837192·SmartAblate™ Adapter Cable AcQMap to Catheter

AcQMap

FDA UDI

ACUTUS MEDICAL, INC.·00850027837475·Maestro Adapter Cable, AcQMap to Generator

Innocor

FDA UDI

Innovision ApS·05713867000155·Innocor cardio-pulmonary function test equipment

MAC

FDA UDI

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.·00840682104838·

AcQMap

FDA UDI

ACUTUS MEDICAL, INC.·00857042007388·Cable, AcQMap Surface ECG Output (AHA) Packaged

ZIO SR Patch

FDA UDI

IRHYTHM TECHNOLOGIES, INC.·00869770000234·ZIO SR ECG Monitoring Service