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510(k) Data Aggregation
K Number
K993307Device Name
ARIA LX CPAP SYSTEMManufacturer
Date Cleared
1999-10-27
(23 days)
Product Code
Regulation Number
868.5905Type
SpecialPanel
AnesthesiologyReference & Predicate Devices
N/A
Why did this record match?
Device Name :
ARIA LX CPAP SYSTEM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Not Found
Device Description
Not Found
AI/ML Overview
The provided text is an FDA 510(k) clearance letter. It states that marketing of the device is permitted but does not contain any information about acceptance criteria, device performance, study details, ground truth establishment, or sample sizes.
Therefore, I cannot answer your request based on the input provided. The letter is a regulatory document confirming substantial equivalence, not a summary of the underlying technical and clinical studies.
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