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510(k) Data Aggregation
K Number
K053360Device Name
AEROLIFE ULTRASONIC NEBULIZER, MODEL P2CManufacturer
Date Cleared
2006-03-23
(111 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
To be used to convert liquid medication into aerosol for inhalation by patients.
Device Description
Not Found
AI/ML Overview
The provided text describes an FDA 510(k) clearance for the AeroLife Model P2C Ultrasonic Nebulizer. It does not contain information about acceptance criteria for a device's performance, nor does it detail a study proving such criteria are met. The document is a regulatory approval letter, not a scientific study report.
Therefore, I cannot provide the requested information based on the given text.
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