Device Name
ACU-HALTManufacturer
Date Cleared
1996-12-30
(384 days)
Product Code
Regulation Number
N/AType
TraditionalAge Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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N/A