510(k) K242618
K242618 is an FDA 510(k) premarket notification submitted by Precision Neuroscience, Corp. for the device "Layer 7-T". The FDA issued a decision of Substantially Equivalent on March 30, 2025. The device falls under product code GYC (Electrode, Cortical), a Class II device regulated under 21 CFR 882.1310.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 30, 2025
- Date Received
- September 3, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Cortical
- Device Class
- Class II
- Regulation Number
- 882.1310
- Review Panel
- NE
- Submission Type