FDA 510(k) Application Details - K210383

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K210383
Device Name	Electrode, Cutaneous
Applicant	Hi-Dow International Inc. 2555 Metro Blvd Maryland Heights, MO 63043 US Other 510(k) Applications for this Company
Contact	Eric Chen 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	02/09/2021
Decision Date	11/12/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review