FDA 510(k) Application Details - K250058

Device Classification Name	Automatic Event Detection Software For Polysomnograph With Electroencephalograph   More FDA Info for this Device
510(K) Number	K250058
Device Name	Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Applicant	Brain Electrophysiology Laboratory Company, LLC 440 E Broadway Ste 200 Eugene, OR 97401 US Other 510(k) Applications for this Company
Contact	Phan Luu Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	OLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/10/2025
Decision Date	04/10/2025
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