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510(k) Data Aggregation
K Number
K961308Device Name
AUDIO 'D' INTIMA CICManufacturer
Date Cleared
1996-05-07
(33 days)
Product Code
Regulation Number
874.3300Type
TraditionalPanel
Ear Nose & ThroatReference & 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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