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OLU — Normalizing Quantitative Electroencephalograph Software Class II

FDA Device Classification

Classification Details

Product Code
OLU
Device Class
Class II
Regulation Number
882.1400
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

Definition

Post-hoc statistical analysis of electroencephalograph signals with comparison to a normative database for interpretation by a qualified user.

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