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510(k) Data Aggregation
Device Name
SCOPETEX(TM)Manufacturer
Date Cleared
1997-05-20
(918 days)
Product Code
Regulation Number
868.5540Type
TraditionalPanel
AnesthesiologyAge 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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