FDA 510(k) Application Details - K223775

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K223775
Device Name	Electrode, Cutaneous
Applicant	South Dakota Partners 205 Hwy 22 E Clear Lake, SD 57226 US Other 510(k) Applications for this Company
Contact	Mike Plunkett 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	12/16/2022
Decision Date	01/03/2023
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