FDA 510(k) Application Details - K233987

Device Classification Name	Device, Sleep Assessment   More FDA Info for this Device
510(K) Number	K233987
Device Name	Device, Sleep Assessment
Applicant	Arbor Medical Innovations, LLC 168 S. Industrial Drive Saline, MI 48176 US Other 510(k) Applications for this Company
Contact	Grant Kruger 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	12/18/2023
Decision Date	06/17/2024
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