Layer 7-T
FDA 510(k) clearance K242618 · decided 2025-03-30
Clearance details
- K-number
- K242618
- Device name
- Layer 7-T
- Applicant
- Precision Neuroscience, Corp.
- Decision
- Substantially Equivalent
- Date received
- 2024-09-03
- Decision date
- 2025-03-30
- Days to decision
- 208 days
- Clearance type
- Traditional
- Product code
- GYC
- Device class
- 2
- Regulation number
- 882.1310
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.