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510(k) Data Aggregation
K Number
K011340Manufacturer
Date Cleared
2001-09-21
(142 days)
Product Code
Regulation Number
876.5980Type
TraditionalReference & 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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K Number
K011343Device Name
LH 500 ENTERAL FEEDING GRAVITY BAG SETManufacturer
Date Cleared
2001-09-21
(142 days)
Product Code
Regulation Number
876.5980Type
TraditionalReference & 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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K Number
K011341Device Name
LH400 YES-SET Y-PORT ENTERAL SPIKE PUMP SETManufacturer
Date Cleared
2001-09-21
(142 days)
Product Code
Regulation Number
876.5980Type
TraditionalReference & Predicate Devices
N/A
Predicate For
N/A
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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