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510(k) Data Aggregation
K Number
K974718Device Name
PERSYST PRISM
Manufacturer
PERSYST DEVELOPMENT CORP.
Date Cleared
1998-03-09
(82 days)
Product Code
GWS, GMS
Regulation Number
882.1420Why did this record match?
Product Code :
GWS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This product is intended for use by a trained EEG reader.
This software is intended for use by a trained EEG technician or neurologist.
Device Description
The Persyst Prism is a software only product. It runs on a personal computer and requires no specialized hardware. It displays digitized EEG signals, power spectra, topographic maps, etc. These functions are all controlled and interpreted by the digitized EEG input is read from a file on the personal computer (or available across the network).
Neither the computer nor the software control the delivery of energy, the administration of parenteral drugs, or another form of life sustaining function to the patient.
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