510(k) K110010
K110010 is an FDA 510(k) premarket notification submitted by Blackrock Microsystems, Inc. for the device "NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM". The FDA issued a decision of Substantially Equivalent on February 9, 2011. The device falls under product code GZL (Electrode, Depth), a Class II device regulated under 21 CFR 882.1330. Blackrock Microsystems, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 9, 2011
- Date Received
- January 3, 2011
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Depth
- Device Class
- Class II
- Regulation Number
- 882.1330
- Review Panel
- NE
- Submission Type