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510(k) Data Aggregation
K Number
K961645Device Name
MRS-2D
Manufacturer
Date Cleared
1996-10-31
(185 days)
Product Code
Regulation Number
882.5050Why did this record match?
Applicant Name (Manufacturer) :
LEXICOR MEDICAL TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
BioLex is indicated for relaxation training using alpha EEG biofeedback. In the protocol for relaxation training, BioLex provides a visual and/or auditory signal that corresponds to the patient's increase in alpha activity as an indicator of achieving a state of relaxation.
Device Description
The NRS-2D is a two channel electrophysiological signal acquisition and biofeedback device. The product is designed for use with a standard IBM PC/AT compatible computer and associated peripheral equipment. When assembled with the computer, the NRS-2D system will acquire EEG and biofeedback data, perform signal spectral analysis and quantification and provide auditory and/or visual feedback. At the user's discretion the NRS-2D can be factory configured as a single channel device.
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