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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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Persyst 13 EEG Review and Analysis Software - 00869732000111

Persyst 13 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
P13
In Commercial Distribution

  • 00869732000111 ()


  • Bioelectrical signal analysis software

Persyst 12 EEG Review and Analysis Software - 00869732000104

Persyst 12 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
P12
In Commercial Distribution

  • 00869732000104 ()


  • Bioelectrical signal analysis software

NeuroMatch - 00850056774000

NeuroMatch is a Software as Medical Device intended for physicians to review EEG data.
LVIS CORPORATION
1.0.4
In Commercial Distribution

  • 00850056774000 ()


  • Bioelectrical signal analysis software

Natus - 00382830058216

Patient Room Alarm Relay Box (IP Version)
XLTEK
023019
In Commercial Distribution

  • 00382830058216 ()


  • Electroencephalograph

Natus - 00382830058209

IP Alarm Controller, Box
XLTEK
022979
In Commercial Distribution

  • 00382830058209 ()


  • Electroencephalograph

Natus - 00382830058575

IP Alarm Relay Box accessory kit
XLTEK
024006
In Commercial Distribution

  • 00382830058575 ()


  • Electroencephalograph

encevis - 09120109830078

encevis is a quantitative EEG trending, spike and seizure detection software. encevis is used for both monitoring and trending of EEG recordings during acquisition and reviewing of processed recordings.
AIT Austrian Institute of Technology GmbH
1.6
In Commercial Distribution

  • 09120109830078 ()


  • Bioelectrical signal analysis software

encevis - 09120109830122

encevis is a quantitative EEG trending, spike and seizure detection software. encevis is used for both monitoring and trending of EEG recordings during acquisition and reviewing of processed recordings.
AIT Austrian Institute of Technology GmbH
1.12
In Commercial Distribution

  • 09120109830122 ()


  • Bioelectrical signal analysis software

NA - 00840682104272

No Description
GE Healthcare Finland Oy
E-ENTROPY-01
In Commercial Distribution

  • 00840682104272 ()


  • Patient monitoring system module, electroencephalographic

OmniME - 00858703006320

Multi-exercise respiratory therapy device with OmniFlow software and sensor, and Synchrony software, electrodes, and sensing devices
ACCELERATED CARE PLUS CORP
100MTS
In Commercial Distribution

  • 00858703006320 ()


  • Bioelectrical signal analysis software
  • Biomechanical function analysis/interactive rehabilitation system
  • Monitoring spirometer, mechanical
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