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510(k) Data Aggregation

    K Number
    K252827

    Validate with FDA (Live)

    Device Name
    IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559)
    Manufacturer
    Drägerwerk AG & Co, Kgaa
    Date Cleared
    2025-12-01

    (87 days)

    Product Code
    DSA
    Regulation Number
    870.2900
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    All
    Reference & Predicate Devices
    K162768
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The IBP cables and IBP adapter cables are intended to forward electrical signals from connected IBP pressure transducer sets to the patient monitor.

    Device Description

    This traditional 510(k) submission comprises six distinct IBP cables and IBP adapter cables [IBP (adapter) cables] to transmit electrical signals acquired from an IBP transducer to the Draeger Vista 300 Patient Monitor.
    The subject devices are passive electrical conductors in the context of invasive blood pressure (IBP) monitoring and do not modify the signal but convey it in an unchanged manner to the Draeger Vista 300 Patient Monitor.

    AI/ML Overview

    N/A

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