FDA 510(k), K181179, BrainScope One
FDA 510(k), K181179, BrainScope One
Device Name: BrainScope One
Manufacturer: Michael E Singer
Device Classification Name: Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
Regulation Number: PIW
Classification Product Code: KXA
Date Received: 05/02/2018
Decision Date: 05/18/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
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