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510(k) Data Aggregation
K Number
K250453Manufacturer
Date Cleared
2025-09-02
(196 days)
Regulation Number
870.1025Type
TraditionalPanel
Cardiovascular (CV)Reference & Predicate Devices
N/A
Why did this record match?
Device Name :
IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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