FDA 510(k) Application Details - K243788

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K243788
Device Name	Electrode, Cutaneous
Applicant	Bioserenity Medical Devices Group 20, rue Berbier du Mets Paris Cedex 13 lle-de-France Paris 75013 FR Other 510(k) Applications for this Company
Contact	Melanie Renaud-Samiri Other 510(k) Applications for this Contact
Regulation Number	882.1320   More FDA Info for this Regulation Number
Classification Product Code	GXY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/09/2024
Decision Date	03/13/2025
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