Manufacturer
Date Cleared
2000-07-18
(21 days)
Product Code
Regulation Number
886.5918Type
SpecialPanel
OphthalmicAge Range
N/A
Reference & Predicate Devices
N/A
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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N/A