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510(k) Data Aggregation
K Number
K071109Device Name
SACS EEG WORKSTATION A7
Manufacturer
Date Cleared
2007-06-07
(50 days)
Product Code
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
SACS MEDICAL AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SACS EEG Workstation A7 is intended to be used for the measurement and recording of the electrical activity in a patient's brain, using electrodes placed on the patient's head.
The SACS EEG Workstation A7 is intended for use by qualified medical personnel trained in the use of electroencephalographs.
Device Description
The SACS EEG Workstation A7 ("SACS A7") is a line-powered electroencephalograph that measures and records the electrical activity in a patient's brain via electrodes placed on the patient's head. The SACS A7 System device is comprised of a flat-panel monitor, an Intel Pentium-based computer with proprietary software installed, a separate EEG amplifier, a separate photic stimulator, and a standard computer keyboard. The components can be mounted on a customer's mobile stand or cart, or on a desk or work table. A USB cable connects the computer to the EEG amplifier, which is in turn connected to patient electrodes that are applied to specified locations on the patient's head. The system is controlled by a Windows XP-based operating system. EEG results are stored either on the Workstation itself in the SACS Database on the hard drive, or on a network server. If results are stored on the SACS Server Database on a network server, they can be reviewed from any SACS Review Workstation.
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