510(k) K252923
K252923 is an FDA 510(k) premarket notification submitted by Iasis Technologies for the device "IASIS i2 Relaxation Neurofeedback System". The FDA issued a decision of Substantially Equivalent on Mar 13, 2026.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 13, 2026
- Date Received
- Sep 15, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No