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Found 2 results
510(k) Data Aggregation
K Number
K004046Manufacturer
Date Cleared
2001-04-26
(118 days)
Product Code
Regulation Number
870.4230Type
TraditionalPanel
CardiovascularReference & Predicate Devices
N/A
Why did this record match?
Device Name :
COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K002591Manufacturer
Date Cleared
2000-09-13
(23 days)
Product Code
Regulation Number
870.4230Type
SpecialPanel
CardiovascularReference & Predicate Devices
N/A
Why did this record match?
Device Name :
COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
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