FDA.reportPublic FDA data

Cardiospy ECG Holter System

Primary DI
05999883490075
Brand
Cardiospy ECG Holter System
Company
LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság
Model
USB-02 Dongle
Catalog number
DEV-00USB-02
Device description
The USB-02 Dongle is the hardware key for Cardiospy software that makes possible the use of Cardiospy ECG Holter recorders (EC-2H, EC-3H or EC-12H) as a system and the management, procession and evaluation of the recorded row data.The universal analysis SW provides full disclosure ECG recordings on channels with a precise automatic QRS and PM detection, template and rhythm analysis, QRS classification, efficient ST, QT, AF, PM, HRV time and frequency based analysis with color coded display and printing with interactive modification possibilities in the automatic analysis in several languages. Export-import and archiving option of the recordings is available.The evaluation software works with a conventional PC- based computer under Win 2000/XP/VISTA , Windows 7, Windows 8, Windows 10 operating systems.The connection between the Holter and computer is performed by using Bluetooth and USB dongle.The Cardiospy analysis software provides ECG records of excellent quality.
Published
2017-12-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MLOElectrocardiograph, Ambulatory, With Analysis Algorithm

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLOElectrocardiograph, Ambulatory, With Analysis AlgorithmCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140847000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140847000CARDIOSPY ECG HOLTER SYSTEMSLabtech Kft.2014-12-05MLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05999883490075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05999883490075059998834900755999883490075

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic long-term ambulatory recording analyserAn electronic device intended to be used for the analysis of long-term (often 24-hours) heart activity data, which has previously been registered by an electrocardiographic long-term ambulatory recorder (Holter), to which the patient was connected and carried upon his or her person.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length67.5Millimeter
Weight50Gram
Width18.5Millimeter
Width53Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+19496796100smerritt@cercacor.com

Regulatory Flags#

DUNS number
520963286
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05999883490006Cardiospy ECG Holter SystemEC-2H2017-12-06
05999883490013Cardiospy ECG Holter SystemEC-3H2017-12-06
05999883490044Cardiospy ECG Holter SystemEC-12H2017-12-06

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Primary DI, Brand, Company table
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