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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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IntelligentVRA Software - 00817020020884

No Description
INTELLIGENT HEARING SYSTEMS CORP.
M815000
In Commercial Distribution

  • 00817020020884 ()


  • Visual-reinforcement audiometer

SmartAudiometer Software - 00817020020877

No Description
INTELLIGENT HEARING SYSTEMS CORP.
M817000
In Commercial Distribution

  • 00817020020877 ()


  • Tone audiometer

SmartTrOAE Software - 00817020020860

No Description
INTELLIGENT HEARING SYSTEMS CORP.
M814000
In Commercial Distribution

  • 00817020020860 ()


  • Bioelectrical signal analysis software

SmartDPOAE Software - 00817020020853

No Description
INTELLIGENT HEARING SYSTEMS CORP.
M813000
In Commercial Distribution

  • 00817020020853 ()


  • Bioelectrical signal analysis software

SmartEP-ASSR Software - 00817020020815

No Description
INTELLIGENT HEARING SYSTEMS CORP.
M811007
In Commercial Distribution

  • 00817020020815 ()


  • Bioelectrical signal analysis software

SmartEP Software - 00817020020808

No Description
INTELLIGENT HEARING SYSTEMS CORP.
M811000
In Commercial Distribution

  • 00817020020808 ()


  • Bioelectrical signal analysis software

EyeSuite Software - 07640132987256

No Description
Haag-Streit AG
i9.0
In Commercial Distribution

  • 07640132987256 ()


  • Medical image management system

EyeSuite Software - 07640132986105

No Description
Haag-Streit AG
i8.2
In Commercial Distribution

  • 07640132986105 ()


  • Medical image management system

ANS1 Software - B322G0011

"ANS1 Software is inetended for use: ANS1 Software is an optional software accessory for use with the following models with datamanagement capabilities: a) TM-Oxi (Oximeter and blood pressure device) and b) SudoPath (Galvanic Skin response) and c) ES-BC (Body Composition Analyzer).When used in combination with TM-Oxi and/or SudoPath, and/or ES-BC devices, the ANS1software uploads the data of the devices, analyzes the data, and then displays the data in ac omputer for enhanced data management. The ANS1 software is intended for use in clinical settings as an aid for health careprofessionals to review, analyze, and evaluate the historical tests results."
LD TECHNOLOGY, LLC
G001
In Commercial Distribution

  • B322G0011 ()


  • Manual-inflation electronic sphygmomanometer, non-portable
  • Skin electrical conductance meter

eCardiostation Software - B147EC0

Software with CardioStation
UNIVERSAL MEDICAL, INC.
eCardiostation Software
In Commercial Distribution

  • B147EC0 ()


  • Electrocardiography telemetric monitoring system
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