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510(k) Data Aggregation
K Number
K964939Manufacturer
Date Cleared
1997-03-06
(86 days)
Product Code
Regulation Number
868.1880Type
TraditionalPanel
AnesthesiologyReference & Predicate Devices
N/A
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Device Name :
THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 PORTABLE PLUS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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