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510(k) Data Aggregation
K Number
K042150Device Name
XLTEK TREX MODEL#10309Manufacturer
Date Cleared
2004-08-27
(18 days)
Product Code
Regulation Number
882.1400Type
SpecialPanel
NeurologyReference & Predicate Devices
N/A
Why did this record match?
Device Name :
XLTEK TREX MODEL#10309
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The XLTEK TREX is intended to be used as an electroencephalograph: to acquire, display, store and archive electroencephalographic signals.
Device Description
Not Found
AI/ML Overview
The provided text is a 510(k) premarket notification approval letter for the XLTEK Trex, an electroencephalograph device. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested.
Therefore, I cannot fulfill your request for this specific document.
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