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510(k) Data Aggregation
K Number
K003999Manufacturer
Date Cleared
2001-06-28
(184 days)
Regulation Number
870.2300Type
TraditionalPanel
CardiovascularReference & Predicate Devices
N/A
Why did this record match?
Device Name :
AVIVA SYSTEM, MODEL SL 2020; AVIVA SLX SYSTEM SYSTEM, MODEL SLX 1010
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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