SOURCE RECORD / S0035
FDA 510(k) K242618 Layer 7-T
FDA 510(k) K242618 Layer 7-T
- Authors or organization
- US FDA
- Published date
- 2025-03-30
- Source type
- regulatory_record
- Technology route
- cortical surface electrode
- Function or setting
- intraoperative recording
- Rights status
- manual_review
Evidence summary
Evidence: Regulatory device status. Key figures: K242618; Class II; 21 CFR 882.1310; substantially equivalent. Limitations: 510(k) SE does not prove chronic BCI efficacy or long-term safety.
Key figures
K242618; Class II; 21 CFR 882.1310; substantially equivalent
Limitations
510(k) SE does not prove chronic BCI efficacy or long-term safety