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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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DeepRhythmAI - 05903021560131

The DeepRhythmAI (DRAI) is a cloud-based software for automated analysis of ECG data. It uses a scalable Application Programming Interface (API) to enable easy integration. The main component of DeepRhythmAI is an automated proprietary deep-learning algorithm, which measures and analyzes ECG data to provide qualified healthcare professional with supportive information for review. DeepRhythmAI can be integrated into medical devices.
MEDICALGORITHMICS S A
Type: DRAI
In Commercial Distribution

  • 05903021560131 ()


  • Cardiopulmonary physiological parameter analysis software

Holter System - 06944413800977

No Description
Edan Instruments, Inc.
SE-2012
In Commercial Distribution

  • 06944413800977 ()


  • Electrocardiograph, professional, multichannel

Holter System - 06944413800960

No Description
Edan Instruments, Inc.
SE-2003
In Commercial Distribution

  • 06944413800960 ()


  • Electrocardiograph, professional, multichannel

Sage 12c - 00815871021425

No Description
Avante
60130H
In Commercial Distribution

  • 00815871021425 ()


  • Electrocardiographic ambulatory recorder

syngo.CT Colonography - 04056869026367

No Description
Siemens Healthcare GmbH
11060620
In Commercial Distribution

  • 04056869026367 ()


  • Full-body CT system

AT-Patch - 08800069700178

No Description
ATsens.co.,Ltd.
ATP-C130
In Commercial Distribution

  • 18800069700175 ()
  • 08800069700178 ()
  • 28800069700172 ()


  • Electrocardiographic long-term ambulatory recording analyser

Cardea SOLO - 10857553006129

Cardea SOLO Analysis Package - ECG analysis software (D300) and data transfer cable (C300).
CARDIAC INSIGHT, INC.
C300/D300
In Commercial Distribution

  • 00857553006122 ()
  • 10857553006129 ()
C300/D300

  • Electrocardiographic ambulatory recorder

Cardea SOLO - 10857553006112

Cardea SOLO Wearable Sensor (M300)
CARDIAC INSIGHT, INC.
M300-5
In Commercial Distribution

  • 10857553006112 ()
  • 00857553006115 ()
M300-5

  • Electrocardiographic ambulatory recorder

EVO Recorder - 10841522127229

PACKAGE, EVO AND PATHFINDER SL
SPACELABS HEALTHCARE (WASHINGTON), INC
EVO Recorder
In Commercial Distribution

  • 10841522127229 ()
040-1761-00

  • Electrocardiographic ambulatory recorder
  • Electrocardiographic long-term ambulatory recording analyser

Stealth System S300 - 20857553006072

Stealth System Wearable Sensor (M300).
CARDIAC INSIGHT, INC.
M300-5
Not in Commercial Distribution

  • 20857553006072 ()
  • 00857553006078 ()
M300-5

  • Electrocardiographic ambulatory recorder
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