Cathvision ApS

Address:Titangade 11,Copenhagen N,DK

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Computer, Diagnostic, Programmable (DQK) (1)

Premarket Exempt

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ECGenius System - 05700002168528 Catalog Number : CVT-0069 R2.0 ECGenius System

Device Description : The ECGenius System is a computerized electrophysiology measurement system desi The ECGenius System is a computerized electrophysiology measurement system designed for both regular and experimental EP studies.The ECGenius System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record clinical data obtained during electrophysiological studies and related procedures. The system is compatible with a 3rd-party stimulator, intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.

Device Class : 2

Duns Number: 305415202

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

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