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510(k) Data Aggregation
K Number
K952347Device Name
A-1050 EEG MONITORManufacturer
Date Cleared
1996-01-16
(242 days)
Regulation Number
882.1400Type
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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