510(k) K110010

NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM by Blackrock Microsystems, Inc. — Product Code GZL

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