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Found 2 results
510(k) Data Aggregation
K Number
K010424Device Name
NEXAN SYSTEM, MODEL NX-301Manufacturer
Date Cleared
2001-09-04
(203 days)
Product Code
Regulation Number
870.2300Type
TraditionalPanel
CardiovascularReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
NEXAN LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K003520Device Name
NEXAN SYSTEM, MODEL NX-300Manufacturer
Date Cleared
2000-12-13
(28 days)
Product Code
Regulation Number
870.2800Type
SpecialPanel
CardiovascularReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
NEXAN LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
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