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510(k) Data Aggregation
K Number
K011151Manufacturer
Date Cleared
2001-05-15
(29 days)
Product Code
Regulation Number
876.1500Type
SpecialReference & Predicate Devices
N/A
Why did this record match?
Device Name :
EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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