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510(k) Data Aggregation
K Number
K003154Device Name
MIZAR, BASIS BE, SANDMAN DIGITALManufacturer
Date Cleared
2001-01-05
(87 days)
Product Code
Regulation Number
882.1835Type
TraditionalPanel
Neurology (NE)Reference & Predicate Devices
N/A
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Device Name :
MIZAR, BASIS BE, SANDMAN DIGITAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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