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510(k) Data Aggregation
K Number
K010590Device Name
NEUROPACK MICRO, MODEL MED-9100A SERIESManufacturer
Date Cleared
2001-06-28
(121 days)
Regulation Number
890.1375Type
TraditionalPanel
NeurologyReference & Predicate Devices
N/A
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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