FDA 510(k) Application Details - K241267

Device Classification Name	Device, Iontophoresis, Other Uses   More FDA Info for this Device
510(K) Number	K241267
Device Name	Device, Iontophoresis, Other Uses
Applicant	Hidroxa Medical AB Bjorndammsterrassen 114 Partille 43342 SE Other 510(k) Applications for this Company
Contact	Sandra Eriksson Mirkovic Other 510(k) Applications for this Contact
Regulation Number	890.5525   More FDA Info for this Regulation Number
Classification Product Code	EGJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/06/2024
Decision Date	10/17/2024
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