FDA.reportPublic FDA data

CARDIO MONITOR CENTER VISION

Primary DI
07290008960427
Brand
CARDIO MONITOR CENTER VISION
Company
SHL TELEMEDICINE INTERNATIONAL LTD.
Model
S-CV8-00
Device description
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.
Published
2023-08-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DPSElectrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290008960427PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290008960427072900089604277290008960427

GMDN Terms#

Term, Definition table
TermDefinition
Cardiology information system application softwareAn application software program, routines, and/or algorithms intended to be used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of cardiology services and facilities. It is typically supplied for installation into a dedicated information system for cardiology or existing mainframe or decentralized computers/networks.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+97235612212info@shl-telemedicine.com

Regulatory Flags#

DUNS number
531817906
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290008960380Smartheart3.3E-486-02025-12-09
07290008960267RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTERE-560-0 / E-561-02023-08-22
07290008960250CardioSen'C4.22023-08-21
07290008960359smartheart3.32019-01-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DPS2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DPS2026-06-03
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B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
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00195278620873MACGe Medical Systems Information Technologies, Inc.DPS2026-03-31
10843997011003Radius VSMMASIMO CORPORATIONDPS2026-02-23
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