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510(k) Data Aggregation
K Number
K955013Device Name
NOVA CO-OXIMETER ANALYZERManufacturer
Date Cleared
1996-04-25
(176 days)
Product Code
Regulation Number
864.7500Type
TraditionalPanel
HematologyReference & Predicate Devices
N/A
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Device Name :
NOVA CO-OXIMETER ANALYZER
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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