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510(k) Data Aggregation
K Number
K002415Device Name
POWERDRIVE 350 OPTIONManufacturer
Date Cleared
2000-08-18
(10 days)
Product Code
Regulation Number
892.1000Type
SpecialPanel
RadiologyReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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