FDA 510(k) Application Details - K234029

Device Classification Name	More FDA Info for this Device
510(K) Number	K234029
Device Name	CEFALY Connected - OTC, CEFALY Connected - Rx
Applicant	CEFALY Technology Rue Louis Plescia, 34 Seraing 4102 BE Other 510(k) Applications for this Company
Contact	Jennifer Trainor Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PCC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/20/2023
Decision Date	07/18/2024
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