510(k) K241267

Hidroxa SE30 by Hidroxa Medical AB — Product Code EGJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2024
Date Received
May 6, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Iontophoresis, Other Uses
Device Class
Class II
Regulation Number
890.5525
Review Panel
PM
Submission Type