FDA 510(k) Application Details - K231532

Device Classification Name	Device, Sleep Assessment   More FDA Info for this Device
510(K) Number	K231532
Device Name	Device, Sleep Assessment
Applicant	ActiGraph, LLC 70 North Baylen Street, Suite 400 Pensacola, FL 32504 US Other 510(k) Applications for this Company
Contact	Brian Bell Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LEL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/26/2023
Decision Date	06/23/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review