510(k) K191346
K191346 is an FDA 510(k) premarket notification submitted by Blackrock Microsystems for the device "Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)". The FDA issued a decision of Substantially Equivalent on February 14, 2020. The device falls under product code GYC (Electrode, Cortical), a Class II device regulated under 21 CFR 882.1310. Blackrock Microsystems has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 14, 2020
- Date Received
- May 20, 2019
- 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