FDA 510(k)
FDA class 2
Substantially Equivalent
🇪🇸 Spain
Inbentus Versatile
K Number: K252663
·
Decision Apr 14, 2026
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
504
Applicant Total
1
Review Days
235
Basic Information
- Device Name
- Inbentus Versatile
- K Number
- K252663
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5895
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Iconic Solutions by Murcia, SL
- Date Received
- August 22, 2025
- Decision Date
- April 14, 2026
- Product Code
- CBK
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | FDA class 2 | Anesthesiology |
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