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Technical Manual – ECGSV3.4 – EU

Additional ECGenius System 3.3 Product Use and Safety Information
Tagged Region: Europe, Status: Obsolete, UDI-DI: (01)05745001034047, Version: 3.4
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ECGenius™ System,  Signal Complexity™,  and PVI Analyzer™ are FDA cleared. ECGenius™ System, Signal Complexity™, and PVI Analyzer™ are not approved for sale in the EU.

Fast Mapping™ is not FDA cleared or approved for sale in the EU.  

This product has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No. 872902 – CathVision Cube.

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