ECGenius System CVT-0069 R2.0 ECGenius System

GUDID 05700002168528

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.

Cathvision ApS

Cardiac electrophysiology analysis system

• Primary Device ID: 05700002168528
• NIH Device Record Key: 046a4c61-4b4f-44e1-8c12-de332ae46393
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECGenius System
• Version Model Number: CVT-0069 R2.0
• Catalog Number: CVT-0069 R2.0 ECGenius System
• Company DUNS: 305415202
• Company Name: Cathvision ApS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05700002168528 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220306

FDA Product Code

• DQK: Computer, Diagnostic, Programmable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-23
• Device Publish Date: 2022-06-15

On-Brand Devices [ECGenius System]

• 05700002168528: The ECGenius System is a computerized electrophysiology measurement system designed for both re
• 05700002168535: The ECGenius™ System is an electrophysiology measurement system and analysis tool used to acqu
• 05745001034009: The ECGenius™ System is an electrophysiology measurement system and analysis tool used to acqu