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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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The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.
NEURALYNX, INC.
288 Channel
In Commercial Distribution

  • 00850011306826 ()
36-0301-0038

  • Electroencephalographic monitoring system
The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.
NEURALYNX, INC.
256 Channel
In Commercial Distribution

  • 00850011306819 ()
36-0301-0037

  • Electroencephalographic monitoring system
The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.
NEURALYNX, INC.
224 Channel
In Commercial Distribution

  • 00850011306802 ()
36-0301-0036

  • Electroencephalographic monitoring system
The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.
NEURALYNX, INC.
192 Channel
In Commercial Distribution

  • 00850011306796 ()
36-0301-0035

  • Electroencephalographic monitoring system
The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.
NEURALYNX, INC.
160 Channel
In Commercial Distribution

  • 00850011306789 ()
36-0301-0034

  • Electroencephalographic monitoring system
The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.
NEURALYNX, INC.
128 Channel
In Commercial Distribution

  • 00850011306772 ()
36-0301-0033

  • Electroencephalographic monitoring system
The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.
NEURALYNX, INC.
96 Channel
In Commercial Distribution

  • 00850011306765 ()
36-0301-0032

  • Electroencephalographic monitoring system
The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.
NEURALYNX, INC.
64 channel
In Commercial Distribution

  • 00850011306758 ()
36-0301-0031

  • Electroencephalographic monitoring system
The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.
NEURALYNX, INC.
32 channel
In Commercial Distribution

  • 00850011306741 ()
36-0301-0030

  • Electroencephalographic monitoring system
MoMe® Software Platform is a web-based remote server software with proprietary algorithms for analysis of ECG data. It analyzes the data via the embedded algorithm and when indicated, data identified by the algorithm is flagged for physician review. The data is sent to the Software Platform from the MoMe® Kardia , a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring.
Infobionic, Inc.
1400
In Commercial Distribution

  • B690MS10 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
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