MeRT System
FDA 510(k) clearance K260402 · decided 2026-06-03
Clearance details
- K-number
- K260402
- Device name
- MeRT System
- Applicant
- Wave Neuroscience
- Decision
- Substantially Equivalent
- Date received
- 2026-02-06
- Decision date
- 2026-06-03
- Days to decision
- 117 days
- Clearance type
- Traditional
- Product code
- SIG
- Device class
- 2
- Regulation number
- 882.5802
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Newport Beach, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.