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510(k) Data Aggregation
K Number
K002969Device Name
XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8Manufacturer
Date Cleared
2000-12-08
(77 days)
Regulation Number
882.1870Type
TraditionalPanel
NeurologyReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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