FDA.reportPublic FDA data

touchECG Windows

Primary DI
08056732652903
Brand
touchECG Windows
Company
CARDIOLINE SPA
Model
touchECG Windows
Catalog number
81019579
Device description
Software that implements a multichannel interpretative electrocardiograph designed to check and diagnose cardiac function.
Published
2025-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DPSElectrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160746000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160746000CARDIOLINE touchECGCardioline S.P.A2016-11-02DPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056732652903PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056732652903080567326529038056732652903

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiograph, professional, multichannelA device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel) and may be intended for resting ECG and/or stress/exercise ECG. It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or telemetry features might also be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+39046196821compliance@cardioline.com

Regulatory Flags#

DUNS number
339465174
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056732654594HD+HD+810180272017-04-11
08056732653610ECG100+ ECG100+805080952017-04-11
08056732654587touchECGtouchECG810195792017-04-12
08056732653450PATIENT CABLE SNAP 10 WIRES AHA FOR HD+63050165 rev. A630501652026-03-19
08056732652422HD+12HD+12810183312025-02-26
08056732652712PATIENT CABLE SNAP 10 WIRES IEC FOR HD+ ORANGE63050104 rev. F630501042025-02-26
08056732652736PATIENT CABLE PLUG 10 WIRES AHA FOR HD+ ORANGE63050106 rev. F63050106 2025-02-26
08056732652491MidmarkMidmark Digital ECG1-100-15502023-12-05

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Primary DI, Brand, Company table
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