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510(k) Data Aggregation
K Number
K963589Device Name
VAIL 3000 BED ENCLOSUREManufacturer
Date Cleared
1997-04-21
(224 days)
Product Code
Regulation Number
880.5100Type
TraditionalPanel
Hematology (HO)Reference & Predicate Devices
N/A
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Device Name :
VAIL 3000 BED ENCLOSURE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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