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510(k) Data Aggregation
K Number
K002105Manufacturer
Date Cleared
2000-12-05
(146 days)
Regulation Number
870.1025Type
TraditionalPanel
CardiovascularReference & Predicate Devices
N/A
Why did this record match?
Device Name :
SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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