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510(k) Data Aggregation
K Number
K010364Device Name
MCC-MIV ONE 2 ONE SOFTWAREManufacturer
Date Cleared
2001-03-22
(43 days)
Product Code
Regulation Number
890.3860Type
TraditionalPanel
Physical MedicineReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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