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510(k) Data Aggregation
K Number
DEN240074Device Name
Pulsenmore ESManufacturer
Date Cleared
2025-10-31
(324 days)
Product Code
Regulation Number
N/AType
DirectPanel
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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