IASIS i2 Relaxation Neurofeedback System
FDA 510(k) clearance K252923 · decided 2026-03-13
Clearance details
- K-number
- K252923
- Device name
- IASIS i2 Relaxation Neurofeedback System
- Applicant
- Iasis Technologies
- Decision
- Substantially Equivalent
- Date received
- 2025-09-15
- Decision date
- 2026-03-13
- Days to decision
- 179 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Murrieta, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.