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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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MyoVision Software - 00853818007088

Software
PRECISION BIOMETRICS INC
Feature Pack C
In Commercial Distribution

  • 00853818007088 ()


  • Bioelectrical signal analysis software

MyoVision Software - 00853818007071

Software
PRECISION BIOMETRICS INC
Feature Pack B
In Commercial Distribution

  • 00853818007071 ()


  • Bioelectrical signal analysis software

MyoVision Software - 00853818007064

Software
PRECISION BIOMETRICS INC
Feature Pack A
In Commercial Distribution

  • 00853818007064 ()


  • Bioelectrical signal analysis software

MyoVision Software - 00853818007057

Software
PRECISION BIOMETRICS INC
Apricot
In Commercial Distribution

  • 00853818007057 ()


  • Bioelectrical signal analysis software

REMI Vigilenz - 00860005388189

REMI Vigilenz AI for Event Detection
Epitel, Inc.
1.x.x
In Commercial Distribution

  • 00860005388189 ()
20104

  • Bioelectrical signal analysis software

REMI - 00860005388158

REMI-Cloud
Epitel, Inc.
2.3
Not in Commercial Distribution

  • 00860005388158 ()


  • Bioelectrical signal analysis software

REMI - 00860005388110

REMI EEG Monitoring Software (Healthcare Facility module) - v. 2.x.x.x
Epitel, Inc.
2.3.0
In Commercial Distribution

  • 00860005388110 ()


  • Bioelectrical signal analysis software

Audhere Software - 00860005068319

No Description
WAHTS HEARING LLC
0.X.X
In Commercial Distribution

  • 00860005068319 ()


  • Tone audiometer

WAHTS - 00860005068302

No Description
WAHTS HEARING LLC
AC 1
In Commercial Distribution

  • 00860005068302 ()


  • Tone audiometer

Persyst ESI powered by Epilog - 05430000733045

Persyst ESI powered by Epilog provides Electrical Source Imaging as a service to a clinical user. The clinical user does not interact directly with the device. In the Persyst ESI powered by Epilog service, the device is used by Epilog operators to generate a report. Persyst ESI powered by Epilog is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects at least 3 years of age for the visualization of human brain function by fusing a variety of EEG information with rendered images of an individualized head model and an individualized MRI image.
Clouds of Care
v2
In Commercial Distribution



  • Bioelectrical signal analysis software
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