FDA 510(k) Application Details - K232915

Device Classification Name	More FDA Info for this Device
510(K) Number	K232915
Device Name	EpiMonitor
Applicant	Empatica Srl Via Stendhal, 36 Milan 20144 IT Other 510(k) Applications for this Company
Contact	Alberto Poli Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	POS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/19/2023
Decision Date	02/15/2024
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