Cardiospy ECG Holter System - The USB-02 Dongle is the hardware key for - LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság

Duns Number:520963286

Device Description: The USB-02 Dongle is the hardware key for Cardiospy software that makes possible the use o 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.

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More Product Details

Catalog Number

DEV-00USB-02

Brand Name

Cardiospy ECG Holter System

Version/Model Number

USB-02 Dongle

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K140847

Product Code Details

Product Code

MLO

Product Code Name

Electrocardiograph, Ambulatory, With Analysis Algorithm

Device Record Status

Public Device Record Key

d03587e9-3fb5-4952-ba54-80857796d7c4

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 06, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LABTECH KERESKEDELMI ÉS MÉRNÖKI SZOLGÁLTATÓ KORLÁTOLT FELELőSSÉGű TÁRSASÁG" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4