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510(k) Data Aggregation
K Number
K042364Device Name
PANBUS DIGITAL EEG & SLEEP ACQUISITION DEVICES
Manufacturer
Date Cleared
2004-09-30
(30 days)
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
LAMONT MEDICAL INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For long term unattended EEG or other electrophysiological signal monitoring and recording.
This device is intended for use by physicians skilled in electroencephalography. These individuals are typically Board Certified Neurologists or Neurophysiologist or the equivalent or Ph.D. level Electroencephalographers.
We recommend placement of electrodes in accordance with the 10.20 International System.
Device Description
Like the predicate WARATAH® and Cardinal® Digital EEG and Sleep Acquisition Devices (WARATAH® Devices), the PANBUS® Digital EEG and Sleep Acquisition Devices (PANBUS® Devices) are provided to Original Equipment Manufactures (OEM) for creation of an electroencephalography (EEG) recording system. Significant PANBUS® Devices are:
I ) Personal computer (PC) interface board;
2) Electrode interface connection (Jackbox);
3) Communication protocol and port (PANBUS);
4) Amplifier(s);
5) Electrode lead wire sets.
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