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510(k) Data Aggregation

    K Number
    K251669
    Device Name
    IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapter
    Manufacturer
    Shanghai Draeger Medical Instrument Co., Ltd.
    Date Cleared
    2025-09-30

    (123 days)

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

    The reusable Dräger IBP adapter cables are intended to forward electrical signals from pressure transducers to Dräger Hemo devices (Pods).

    Device Description

    This traditional 510(k) submission covers 15 distinct IBP transducer adapter cables [also referred to as IBP adapter cables] developed and manufactured by Shanghai Draeger Medical Instrument Co., Ltd., based in Shanghai, China. These devices are passive electrical conductors in the context of invasive blood pressure (IBP) monitoring used to transmit electrical signals acquired from an IBP transducer (not part of this submission) to an external IBP Module (Pod) within a patient monitoring system (not part of this submission). They do not modify the signal but convey it in an unchanged manner to the monitoring device.

    The Pod is referring to the MPod- QuadHemo and Mcable- DualHemo.

    AI/ML Overview

    N/A

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