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510(k) Data Aggregation
K Number
K060523Device Name
NEUROPORT NEURAL SIGNAL PROCESSING SYSTEM
Manufacturer
CYBERKINETICS, INC.
Date Cleared
2006-03-28
(29 days)
Product Code
OMC, CLA, GWQ
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
CYBERKINETICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Cyberkinetics Neurotechnology Systems, Inc. NeuroPort System is for temporary (< 30 days) recording and monitoring of brain electrical activity.
Device Description
The NeuroPort System, when connected to the NeuroPort Array Electrode, supports recording and display of local field potentials and extra cellular spikes from the brain. The NeuroPort Array is not modified by this 510(k) submission. The NeuroPort Electrode Array has 100 electrode contacts on a substrate of 4mm. The NeuroPort Electrode array is implanted in the cortex of the brain for less than 30 days. The NeuroPort Electrode Array passes neural activity of the brain cortex to the NeuroPort System through a Patient Cable assembly. The modification described within this 510(k) submission is summarized as: a) the addition of an impedance test switch to the Patient Cable, b) a hardware change to support automated impedance testing of the NeuroPort Electrode Array, and c) a software change to support automated impedance testing of the NeuroPort Electrode Array.
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K Number
K042384Device Name
NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM
Manufacturer
CYBERKINETICS, INC. (CKI)
Date Cleared
2005-03-29
(209 days)
Product Code
GZL
Regulation Number
882.1330Why did this record match?
Applicant Name (Manufacturer) :
CYBERKINETICS, INC. (CKI)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NeuroPort™ Array System (Neuroport Electrode) is intended for temporary (<30 days) recording and monitoring of brain electrical activity.
Device Description
The NeuroPort™ Array System (Neuroport Electrode) is comprised of a base approximately 4 mm x 4 mm dimensionally with 100 microelectrodes. Each microelectrode is approximately 1 mm long. The lead connects the microelectrode array to the percutaneous pedestal connector.
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K Number
K042626Device Name
NEUROPORT NEURAL SIGNAL PROCESSOR (NSP) SYSTEM
Manufacturer
CYBERKINETICS, INC.
Date Cleared
2005-03-28
(182 days)
Product Code
GWQ, GWO
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
CYBERKINETICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NeuroPort™ NSP System is intended for temporary (<30 days) recording and monitoring of brain electrical activity.
The intended use of the Cyberkinetics, Inc. Neuroport Neural Signal Processor System is monitoring of brain electrical activity.
Device Description
The Neuroport Neural Signal Processing (NSP) System is intended for recording and monitoring. Its functionality includes routine brain activity recording, monitoring, retrieval and replay. The Neuroport supports up to 96 channels of recording and is comprised of the following hardware components: Patient Cable, Amplifier, CPU and a Display monitor. The Neuroport System also includes the following software functions: acquisition, amplification and display.
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