510(k) K252663
K252663 is an FDA 510(k) premarket notification submitted by Iconic Solutions by Murcia, SL for the device "Inbentus Versatile". The FDA issued a decision of Substantially Equivalent on April 14, 2026. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895.
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