FDA 510(k) Application Details - K223628

Device Classification Name	Reduced- Montage Standard Electroencephalograph   More FDA Info for this Device
510(K) Number	K223628
Device Name	Reduced- Montage Standard Electroencephalograph
Applicant	Neba Health, LLC 2052 Gordon Highway, Ste B. Augusta, GA 30909 US Other 510(k) Applications for this Company
Contact	Howard Merry Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	OMC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/05/2022
Decision Date	03/02/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review