K-number	K223628
Device name	NEBA® Compact EEG2R Mobile Headset
Applicant	Neba Health, LLC
Product code	OMC
Device class	Class II
Decision date	Mar 2, 2023
Decision	Substantially Equivalent
Regulation	882.1400

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Source

View the full FDA submission: accessdata.fda.gov

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NEBA® Compact EEG2R Mobile Headset

Everything you need for a 510(k) submission. Nothing you don't.