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Amplitude-Integrated Electroencephalograph

FDA product code OMA · 15 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
1979-09-04 – 2020-01-30

Measure and record electrical activity of the brain by acquisition of amplitude-integrated electroencephalograph (electroencephalograph signals that have been filtered and displayed in a specific manner).

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