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510(k) Data Aggregation
K Number
K961707Device Name
TRACH-EZE CLOSED VENTILATION SUCTION SYSTEMManufacturer
Date Cleared
1997-03-11
(313 days)
Product Code
Regulation Number
868.6810Type
TraditionalPanel
AnesthesiologyReference & Predicate Devices
N/A
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Applicant Name (Manufacturer) :
SORENSON CRITICAL CARE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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