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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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STAR Apollo - 00860009793507

The STAR Apollo Mapping System is a cardiac mapping method that is based on proprietary algorithms developed to identify localized sources of atrial activation during AF. The STAR Apollo Mapping System does not aim to elucidate the mechanism of AF, rather it seeks to reveal the anatomical location of regions where activation may be originating from, regardless of mechanism. This is based on a very simple and fundamental principle that the source of activation will have activation emerging from it in multiple directions, but not progressing towards it.
Rhythm AI Inc.
STAR Apollo Mapping System
Not in Commercial Distribution

  • 00860009793507 ()
STAR Apollo Mapping System

  • Cardiac mapping system application software

CAM-USB - 00840682109772

No Description
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
INTERFACE V2
In Commercial Distribution

  • 00840682109772 ()


  • Cardiac stress exercise monitoring system

CAM-USB - 00840682109611

No Description
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
INTERFACE A/T V2
In Commercial Distribution

  • 00840682109611 ()


  • Cardiac stress exercise monitoring system

CardioSoft - 00840682105170

CARDIOSOFT V6.73
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
V6.73
In Commercial Distribution

  • 00840682105170 ()


  • Electrocardiograph, professional, multichannel

CS - 00840682105156

CS V6.73
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
V6.73
Not in Commercial Distribution

  • 00840682105156 ()


  • Electrocardiograph, professional, multichannel

CASE - 00840682105088

CASE V6.7
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
V6.7
In Commercial Distribution

  • 00840682105088 ()


  • Electrocardiograph, professional, multichannel

NA - 00840682104104

No Description
GE Healthcare Finland Oy
E-COP-01
In Commercial Distribution

  • 00840682104104 ()


  • Patient monitoring system module, multifunction

NA - 00840682104098

No Description
GE Healthcare Finland Oy
E-COPSv-01
In Commercial Distribution

  • 00840682104098 ()


  • Patient monitoring system module, multifunction

Carto 3 - 10846835012576

No Description
Biosense Webster Inc
D128624
In Commercial Distribution

  • 10846835012576 ()
D128624

  • Electrical-only medical device connection cable, reusable

NOGA XP - 10846835011678

NOGA XP-Cardiac Mapping System
BIOSENSE WEBSTER (ISRAEL) LTD.
FG170000
Not in Commercial Distribution

  • 10846835011678 ()
FG170000

  • Cardiac mapping system
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