510(k) K252663

Inbentus Versatile by Iconic Solutions by Murcia, SL — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2026
Date Received
August 22, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Facility Use
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type