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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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System Software for NeuroStar Mobile Console
NEURONETICS, INC.
Version 3.5
In Commercial Distribution

  • 00850005944089 ()
83-00054-000

  • Magnetic neural stimulation system
System Software for NeuroStar Mobile Console
NEURONETICS, INC.
Version 3.7
In Commercial Distribution

  • 00850005944508 ()
83-00054-000

  • Magnetic neural stimulation system
System Software for NeuroStar Mobile Console
NEURONETICS, INC.
Version 3.8
In Commercial Distribution

  • 00850005944355 ()
83-00093-000

  • Magnetic neural stimulation system
The Eko Analysis Software is intended to provide support to the physician in the evaluation of patients' heart sounds and ECG’s. The software analyzes simultaneous ECG and heart sounds. The software will detect the presence of suspected murmurs in the heart sounds. The software also detects the presence of atrial fibrillation and normal sinus rhythm from the ECG signal. In addition, it calculates certain cardiac time intervals such as heart rate, QRS duration and EMAT. The software does not distinguish between different kinds of murmurs and does not identify other arrhythmias. It is not intended as a sole means of diagnosis. The interpretations of heart sounds and ECG offered by the software are only significant when used in conjunction with physician over-read and is for use on adults (> 18 years)
Eko Devices, Inc.
EAS
In Commercial Distribution

  • 00850010298030 ()


  • Cardiopulmonary physiological parameter analysis software
Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012).
EARLENS CORPORATION
ELF003
In Commercial Distribution

  • 00850013007417 ()
ELF003

  • Audiometric/hearing device software
SFW 9735911 STEALTH S8 STEREOTAXY
MEDTRONIC NAVIGATION, INC.
9735911
In Commercial Distribution

  • 00643169878211 ()


  • Neurological stereotactic surgery system
SFW 9735910 STEALTH S8 DBS
MEDTRONIC NAVIGATION, INC.
9735910
In Commercial Distribution

  • 00643169878204 ()


  • Neurological stereotactic surgery system
SW APP 9735762 STEALTH S8 APP
MEDTRONIC NAVIGATION, INC.
9735762
In Commercial Distribution

  • 00643169865341 ()


  • Multi-purpose stereotactic surgery system
SFW KIT 9735739 STEALTH S8 STEREOTX
MEDTRONIC NAVIGATION, INC.
9735739
In Commercial Distribution

  • 00643169838987 ()


  • Neurological stereotactic surgery system
SFW KIT 9735738 STEALTH S8 CRN DBS
MEDTRONIC NAVIGATION, INC.
9735738
In Commercial Distribution

  • 00643169838970 ()


  • Neurological stereotactic surgery system
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