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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 NeXus software is intended to provide (near) real-time biofeedback and neurofeedback in the form of information, visual and auditory signals, corresponding to the state of one or more physiological parameters, so that a patient can learn voluntary control of these parameters. The software shall be used on a personal computer (in a medical office environment) in combination with compatible signal acquisition devices and sensor accessories to perform its intended use. The software is designed for medical use, not restricted to a specific medical indication. It is intended to be used within a medical office environment by, or under supervision of, a health professional (novice user, technical knowledge, normal eyesight, possibly achieved with the aid of glasses). The software is not intended for use in a life support application nor is it intended for diagnostic purposes.
Mind Media Europe B.V.
1.0.204.6
In Commercial Distribution

  • 08719481550332 ()


  • Biofeedback system application software
"ANS1 Software is inetended for use: ANS1 Software is an optional software accessory for use with the following models with datamanagement capabilities: a) TM-Oxi (Oximeter and blood pressure device) and b) SudoPath (Galvanic Skin response) and c) ES-BC (Body Composition Analyzer).When used in combination with TM-Oxi and/or SudoPath, and/or ES-BC devices, the ANS1software uploads the data of the devices, analyzes the data, and then displays the data in ac omputer for enhanced data management. The ANS1 software is intended for use in clinical settings as an aid for health careprofessionals to review, analyze, and evaluate the historical tests results."
LD TECHNOLOGY, LLC
G001
In Commercial Distribution

  • B322G0011 ()


  • Manual-inflation electronic sphygmomanometer, non-portable
  • Skin electrical conductance meter
No Description
INTELLIGENT HEARING SYSTEMS CORP.
M815000
In Commercial Distribution

  • 00817020020884 ()


  • Visual-reinforcement audiometer
No Description
INTELLIGENT HEARING SYSTEMS CORP.
M817000
In Commercial Distribution

  • 00817020020877 ()


  • Tone audiometer
No Description
INTELLIGENT HEARING SYSTEMS CORP.
M814000
In Commercial Distribution

  • 00817020020860 ()


  • Bioelectrical signal analysis software
No Description
INTELLIGENT HEARING SYSTEMS CORP.
M813000
In Commercial Distribution

  • 00817020020853 ()


  • Bioelectrical signal analysis software
No Description
INTELLIGENT HEARING SYSTEMS CORP.
M811007
In Commercial Distribution

  • 00817020020815 ()


  • Bioelectrical signal analysis software
No Description
INTELLIGENT HEARING SYSTEMS CORP.
M811000
In Commercial Distribution

  • 00817020020808 ()


  • Bioelectrical signal analysis software
Bloodstream Software is a standalone software application used in blood screening. Bloodstream Software may be configured to connect to instrumentation in a blood screening facility including pipetting systems (poolers), automation software (a track system), blood testing instrumentation, and Laboratory Information Systems (LIS). Bloodstream Software also contains a user interface (UI) that allows users of Bloodstream Software to monitor the testing progress of donor samples in their lab, as well as allowing limited interaction in the testing process, such as modifying or canceling orders, or reviewing and approving results.
DATA INNOVATIONS LLC
1.2
In Commercial Distribution

  • B180BSB01120 ()
BSB01

  • Blood bank information system application software
Bloodstream Software is a standalone software application used in blood screening. Bloodstream Software may be configured to connect to instrumentation in a blood screening facility including pipetting systems (poolers), automation software (a track system), blood testing instrumentation, and Laboratory Information Systems (LIS). Bloodstream Software also contains a user interface (UI) that allows users of Bloodstream Software to monitor the testing progress of donor samples in their lab, as well as allowing limited interaction in the testing process, such as modifying or canceling orders, or reviewing and approving results.
DATA INNOVATIONS LLC
1.1
In Commercial Distribution

  • B180BSB01110 ()
BSB01

  • Blood bank information system application software
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