Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The battery powered Cardiospy ECG Holter System provides 1, 2 channel recordings, depending on the recorder and patient cable type being used. The Cardiospy ECG Holter System includes a recorder, an USB dongle (for bluetooth communication) and the Cardiospy software. The Class II medical device is intended to acquire, record and store up to 24, 48, 72 hours and 1 week of ECG data of patients that have been connected to the recorder and are undergoing Holter monitoring and to support the medical staff in analyzing and deciding the proper and adequate diagnosis. The cardiac data and analysis provided by Cardiospy ECG Holter System will be reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns. 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.
LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság
EC-2H
In Commercial Distribution

  • 05999883490006 ()

  • Length: 67.5 Millimeter
  • Width: 53 Millimeter
  • Width: 18.5 Millimeter
  • Weight: 50 Gram


  • Electrocardiographic long-term ambulatory recording analyser
Holter Monitor
MEMTEC CORPORATION
Model 950-3CH
In Commercial Distribution

  • 00860002827308 ()
1

  • Electrocardiographic long-term ambulatory recording analyser
IQ HOLTER PLUG-IN SOFTWARE v10.0.6: New Software Release for Midmark Digital Holter.
MIDMARK CORPORATION
P/N 4-100-3140
In Commercial Distribution

  • 00841709118067 ()


  • Electrocardiographic long-term ambulatory recording analyser
DR200 holter recorder w/ 7L patient cable
Northeast Monitoring, Inc.
DR200 7L
In Commercial Distribution

  • M581NEMK960 ()

  • Length: 8.6 Centimeter
  • Width: 6.0 Centimeter
  • Depth: 2.0 Centimeter
  • Weight: 70.9 Gram
NEMK96

  • Electrocardiographic long-term ambulatory recording analyser
DR200 holter recorder w/ 5L patient cable
Northeast Monitoring, Inc.
DR200 5L
In Commercial Distribution

  • M581NEMK950 ()

  • Length: 8.6 Centimeter
  • Width: 6.0 Centimeter
  • Depth: 2.0 Centimeter
  • Weight: 70.9 Gram
NEMK95

  • Electrocardiographic long-term ambulatory recording analyser
DR200 holter recorder w/ 2L patient cable
Northeast Monitoring, Inc.
DR200 2L
In Commercial Distribution

  • M581NEMK940 ()

  • Length: 8.6 Centimeter
  • Width: 6.0 Centimeter
  • Depth: 2.0 Centimeter
  • Weight: 70.9 Gram
NEMK94

  • Electrocardiographic long-term ambulatory recording analyser
LX Event Tool (TelePro)
Northeast Monitoring, Inc.
LX Event Tool
In Commercial Distribution

  • M581NEMK1950 ()
NEMK195

  • Electrocardiographic long-term ambulatory recording analyser
DR400 holter recorder with NEMEL002/003 patches
Northeast Monitoring, Inc.
DR400
In Commercial Distribution

  • M581NEMK1570 ()

  • Length: 6.7 Centimeter
  • Width: 3.8 Centimeter
  • Depth: 1.2 Centimeter
  • Weight: 35 Gram
NEMK157

  • Electrocardiographic long-term ambulatory recording analyser
Gateway NEMK156
Northeast Monitoring, Inc.
Gateway
In Commercial Distribution

  • M581NEMK1560 ()

  • Width: 3.8 Centimeter
  • Length: 6.7 Centimeter
  • Depth: 1.2 Centimeter
  • Weight: 35 Gram
NEMK156

  • Electrocardiographic long-term ambulatory recording analyser
No Description
Northeast Monitoring, Inc.
DR300 7L
In Commercial Distribution

  • M581NEMK1550 ()

  • Length: 8.6 Centimeter
  • Width: 6.0 Centimeter
  • Depth: 2.0 Centimeter
  • Weight: 70.9 Gram
NEMK155

  • Electrocardiographic long-term ambulatory recording analyser
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