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510(k) Data Aggregation
Device Name
LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEMManufacturer
Date Cleared
2001-08-23
(149 days)
Regulation Number
870.5310Type
TraditionalPanel
CardiovascularAge Range
N/A
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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