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510(k) Data Aggregation
K Number
K023771Device Name
SYNAMPS2
Manufacturer
NEUROSCAN
Date Cleared
2003-02-06
(86 days)
Product Code
GWQ
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
NEUROSCAN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Neuroscan SynAmps2 system is intended for measuring recording of the electrical activity of a patient's brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG. The system is intended for the EEG and long/middle/short-latency EP registration in the research environment. The system is intended to be used by qualified/trained EEG technologists and/or physicians. The data acquired must be interpreted by qualified physicians.
Device Description
The SynAmps2® Amplifier System is an EEG/ERP/EP amplifier and data acquisition system. The amplifier and data acquisition electronics are housed in a small enclosure (Headbox) placed near the patient, and into which individual electrodes, collections of electrodes, may be connected. Additionally a high density electrode cap connector is provided on the Headbox. The Headbox also contains a connector for the interconnect cable to the System Unit.
The System Unit is slightly larger than the Headbox and serves as an interface between up to four Headboxes and the host computer.
The system operates under the software control of a host computer over a USB 2.0 interface. Data flows from the SynAmps2 amplifier over this interface. Multiple System Units may be connected to the host, to obtain systems of up to 512 channels.
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K Number
K023536Device Name
NUAMPS
Manufacturer
NEUROSCAN
Date Cleared
2003-01-15
(86 days)
Product Code
OLT, GWQ
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
NEUROSCAN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Neuroscan Nuamps® system is intended for the measuring, recording and analysis of the electrical activity of a patient's brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical setting for EEG. The system is intended for the EEG and long/middle-latency EP registration in the research environment.
Device Description
The Neuroscan Nuamps® is a 40-channel EEG amplifier capable of direct current (DC) recording, including signal amplification, analog-to-digital conversion, and filtering. Nuamps® permits high-speed simultaneous sampling, acquisition and transfer of data host computer that controls, displays, and stores the acquired data. Nuamps®'s software routines separately control each channel and perform real-time digital filtering. Nuamps® software measures and analyzes EEG signals and performs analysis of complete data sets, calculates compressed spectrum arrays (CSA), and presents results as annotated signal plots or topographic/tomographic maps in real-time two or three-dimensional (2/3-D) context. Nuamps® is optically isolated and transformers are available for line voltages of 100, 120, 230, VAC.
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K Number
K000865Device Name
QUIK-CAP
Manufacturer
NEUROSCAN
Date Cleared
2000-04-18
(32 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
NEUROSCAN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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