CARDIO MONITOR CENTER VISION

GUDID 07290008960427

The Cardio Monitor Center Vision™ is a stand-alone medical device software operating on the physical or virtual personal computer in the organizational network and designed to work in combination with the medical device (remote personal ECG transmitter) to receive medical data (digital ECG data as an input) converting it to the interpretable ECG graph (software output). The Cardio Monitor Centre Vision displays 12 ECG leads ECG and Rhythm strip. The software received the data via proxy server and converts it to the graph of voltage versus time, displaying the heart's electrical forces, as viewed from 12 different electrical perspectives (points of view) - 12 leads, created by electrodes touching the skin.

SHL TELEMEDICINE INTERNATIONAL LTD.

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Primary Device ID07290008960427
NIH Device Record Key0fdfd5c1-a692-4b0b-942a-547d910847b6
Commercial Distribution StatusIn Commercial Distribution
Brand NameCARDIO MONITOR CENTER VISION
Version Model NumberS-CV8-00
Company DUNS531817906
Company NameSHL TELEMEDICINE INTERNATIONAL LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+97235612212
Emailinfo@shl-telemedicine.com
Phone+97235612212
Emailinfo@shl-telemedicine.com
Phone+97235612212
Emailinfo@shl-telemedicine.com
Phone+97235612212
Emailinfo@shl-telemedicine.com
Phone+97235612212
Emailinfo@shl-telemedicine.com
Phone+97235612212
Emailinfo@shl-telemedicine.com
Phone+97235612212
Emailinfo@shl-telemedicine.com
Phone+97235612212
Emailinfo@shl-telemedicine.com
Phone+97235612212
Emailinfo@shl-telemedicine.com
Phone+97235612212
Emailinfo@shl-telemedicine.com
Phone+97235612212
Emailinfo@shl-telemedicine.com
Phone+97235612212
Emailinfo@shl-telemedicine.com
Phone+97235612212
Emailinfo@shl-telemedicine.com
Phone+97235612212
Emailinfo@shl-telemedicine.com
Phone+97235612212
Emailinfo@shl-telemedicine.com
Phone+97235612212
Emailinfo@shl-telemedicine.com
Phone+97235612212
Emailinfo@shl-telemedicine.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290008960427 [Primary]

FDA Product Code

DPSElectrocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-30
Device Publish Date2023-08-22

Devices Manufactured by SHL TELEMEDICINE INTERNATIONAL LTD.

07290008960267 - RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER2023-08-30 The Cardio'R is an event recorder that helps physician's document heart problems, which may not be found during a routine ECG ex
07290008960427 - CARDIO MONITOR CENTER VISION2023-08-30The Cardio Monitor Center Vision™ is a stand-alone medical device software operating on the physical or virtual personal computer in the organizational network and designed to work in combination with the medical device (remote personal ECG transmitter) to receive medical data (digital ECG data as an input) converting it to the interpretable ECG graph (software output). The Cardio Monitor Centre Vision displays 12 ECG leads ECG and Rhythm strip. The software received the data via proxy server and converts it to the graph of voltage versus time, displaying the heart's electrical forces, as viewed from 12 different electrical perspectives (points of view) - 12 leads, created by electrodes touching the skin.
07290008960427 - CARDIO MONITOR CENTER VISION2023-08-30 The Cardio Monitor Center Vision™ is a stand-alone medical device software operating on the physical or virtual personal compu
07290008960250 - CardioSen'C2023-08-29 The CardioSen’C is a personal, hand-held device, enabling an individual to immediately transmit a 12-lead ECG from anywhere an
07290008960359 - smartheart2019-02-06 The smartheart is a personal, hand-held battery powered, 12 lead EG and rhythm strip device with Bluetooth connection. The smart

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