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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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Natus - 05713315005893

HB 8 kHz headset, jack connector
Natus Medical Denmark ApS
8-75-435
In Commercial Distribution

  • 05713315005893 ()
8-75-435

  • Tone audiometer

GN Otometrics A/S - 05713315004506

No Description
Natus Medical Denmark ApS
PATIENT RES.,M-DIN, GRAY
Not in Commercial Distribution

  • 05713315004506 ()


  • Tone audiometer

GN Otometrics A/S - 05713315004032

No Description
Natus Medical Denmark ApS
Patient Signal Switch (grey)
Not in Commercial Distribution

  • 05713315004032 ()


  • Tone audiometer

GN Otometrics A/S - 05713315000737

No Description
Natus Medical Denmark ApS
Patient Responder (Grey)
Not in Commercial Distribution

  • 05713315000737 ()


  • Tone audiometer

GN Otometrics A/S - 05713315000720

No Description
Natus Medical Denmark ApS
Patient Responder (Blue)
Not in Commercial Distribution

  • 05713315000720 ()


  • Tone audiometer

GN Otometrics A/S - 05713315000713

No Description
Natus Medical Denmark ApS
Patient Responder (Red)
Not in Commercial Distribution

  • 05713315000713 ()


  • Tone audiometer

Persyst 15 EEG Review and Analysis Software - 00869732000166

Persyst 15 EEG Review and Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.
Persyst Development Corp
P15
In Commercial Distribution

  • 00869732000166 ()


  • Bioelectrical signal analysis software

Persyst Mobile App - 00869732000142

This is an application intended to be used by neurologists who are monitoring or reviewing EEGs. It is part of a larger system provided by Persyst.
Persyst Development Corp
App for Web
Not in Commercial Distribution

  • 00869732000142 ()


  • Bioelectrical signal analysis software

Persyst Mobile App - 00869732000135

The Persyst Mobile App is a software application that can be executed on a mobile platform. It is capable of displaying the original EEG data, and quantitative analysis of EEG data generated by the Persyst EEG Review and Analysis Software. This Mobile App is intended to be used by qualified medical practitioners who will exercise professional judgement in using the information.
Persyst Development Corp
Persyst Mobile App
In Commercial Distribution

  • 00869732000135 ()


  • Bioelectrical signal analysis software

Persyst 14 Review and Analysis Software - 00869732000128

Persyst 14 EEG Review and Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.
Persyst Development Corp
P14
In Commercial Distribution

  • 00869732000128 ()


  • Bioelectrical signal analysis software
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