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510(k) Data Aggregation
K Number
K002153Device Name
ULTRASONIC NEBULIZER, MODEL NE-520Manufacturer
Date Cleared
2001-03-13
(239 days)
Product Code
Regulation Number
868.5630Type
TraditionalPanel
AnesthesiologyReference & 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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