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510(k) Data Aggregation
K Number
K000892Manufacturer
Date Cleared
2000-06-16
(88 days)
Regulation Number
882.1400Type
TraditionalPanel
NeurologyReference & Predicate Devices
N/A
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Device Name :
DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, N-EEG AND ACCESSORIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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