FDA 510(k) Application Details - K242346

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K242346
Device Name	Electrode, Cutaneous
Applicant	Natus Manufacturing Limited IDA Business Park Gort IE Other 510(k) Applications for this Company
Contact	Sanjay Mehta 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	08/07/2024
Decision Date	08/29/2024
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	Y
Expedited Review