Device Name
REFLECTION, TANDEM UNIPOLARManufacturer
Date Cleared
2007-10-05
(162 days)
Regulation Number
888.3358Type
TraditionalAge 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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N/A