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Normalizing Quantitative Electroencephalograph Software

FDA product code OLU · 12 cleared devices

Class 2 Neurology
Regulation
21 CFR 882.1400
Review panel
NE
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
1991-07-30 – 2026-06-12

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

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