FDA 510(k) Application Details - K180627

Device Classification Name	Device, Iontophoresis, Specific Uses   More FDA Info for this Device
510(K) Number	K180627
Device Name	Device, Iontophoresis, Specific Uses
Applicant	ELITechGroup Inc. 370 W 1700 S Logan, UT 84321 US Other 510(k) Applications for this Company
Contact	Stacey Pahulu Other 510(k) Applications for this Contact
Regulation Number	890.5525   More FDA Info for this Regulation Number
Classification Product Code	KTB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/09/2018
Decision Date	07/27/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review