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510(k) Data Aggregation
K Number
K110010Device Name
NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM
Manufacturer
BLACKROCK MICROSYSTEMS, INC
Date Cleared
2011-02-09
(37 days)
Product Code
GZL
Regulation Number
882.1330Why did this record match?
Applicant Name (Manufacturer) :
BLACKROCK MICROSYSTEMS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NeuroPort™ Electrode (SIROF) 1.0 mm and 1.5 mm are indicated for temporary (<30 days) recording and monitoring of brain electrical activity.
Device Description
The NeuroPort™ Electrode (SIROF) detects the electrical activity of cortical neurons during sub-chronic-monitoring procedures for less than thirty consecutive days. All of the components in the NeuroPort™ Electrode (SIROF) are passive and are intended exclusively for recording applications: monitoring brain electrical activity, defining the location of the epileptogenic foci and brain mapping.
The NeuroPort™ Electrode (SIROF) consists of high impedance electrodes. The NeuroPort™ Electrode (SIROF) has 100 electrode contacts on a silicon substrate of 4mm by 4mm.
The electrodes provide the patient contact device. The electrodes connect the users recording and monitoring equipment. The electrodes are used under the supervision of a physician. Physicians in the areas of biopotential recording and monitoring understand the use of depth electrodes.
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