FDA 510(k) Application Details - K250515

Device Classification Name	More FDA Info for this Device
510(K) Number	K250515
Device Name	EpiMonitor
Applicant	Empatica Srl Via Stendhal 36 Milano 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	02/21/2025
Decision Date	06/19/2025
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