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510(k) Data Aggregation

    K Number
    K960616
    Device Name
    VITAFLOW SUCTION/ASPIRATION TUBING SET
    Manufacturer
    VITAL CONCEPTS, INC.
    Date Cleared
    1996-05-06

    (83 days)

    Product Code
    BYY
    Regulation Number
    880.6740
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    BYY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    Device Description
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    K Number
    K960218
    Device Name
    CONNECTING TUBING
    Manufacturer
    CUSTOM PACK RELIABILITY
    Date Cleared
    1996-03-28

    (72 days)

    Product Code
    BYY
    Regulation Number
    880.6740
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    BYY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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    K Number
    K955149
    Device Name
    MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REEL
    Manufacturer
    BIO-MEDICAL DEVICES, INC.
    Date Cleared
    1996-01-24

    (72 days)

    Product Code
    BYY
    Regulation Number
    880.6740
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    BYY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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    K Number
    K955151
    Device Name
    MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATOR
    Manufacturer
    BIO-MEDICAL DEVICES, INC.
    Date Cleared
    1996-01-24

    (72 days)

    Product Code
    BYY
    Regulation Number
    880.6740
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    BYY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K955150
    Device Name
    MAXI-FLOW
    Manufacturer
    BIO-MEDICAL DEVICES, INC.
    Date Cleared
    1996-01-23

    (71 days)

    Product Code
    BYY
    Regulation Number
    880.6740
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    BYY

    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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