Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Reduced- Montage Standard Electroencephalograph

FDA product code OMC · 27 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
1978-08-23 – 2026-06-30

Acquire, display, store, and archive electroencephalographic signals from the brain using a user-specified and/or sponsor-specified locations with a reduced array (i.e. less than < 16) of electrodes

↑