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510(k) Data Aggregation
K Number
K970391Manufacturer
Date Cleared
1997-03-06
(31 days)
Product Code
Regulation Number
870.5310Type
TraditionalPanel
CardiovascularReference & Predicate Devices
N/A
Why did this record match?
Device Name :
QUANTUM EDGE PEDIATRIC DEFIRBRILLATION ELECTRODES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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