FDA 510(k) Application Details - K231068

Device Classification Name	Automatic Event Detection Software For Full-Montage Electroencephalograph   More FDA Info for this Device
510(K) Number	K231068
Device Name	Automatic Event Detection Software For Full-Montage Electroencephalograph
Applicant	Holberg EEG AS Fj°sangerveien 70A Bergen 5068 NO Other 510(k) Applications for this Company
Contact	Smriti Franklin Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	OMB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/14/2023
Decision Date	01/07/2024
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