BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Patient Monitoring Cable (SpO2 Extension Cable)

    K Number: K192404 · Decision Jun 22, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    139
    Registration Numbers
    139
    Same Product Code
    104
    Applicant Total
    3
    Review Days
    293

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    Basic Information

    Device Name
    Patient Monitoring Cable (SpO2 Extension Cable)
    K Number
    K192404
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Coreray Technology, Ltd.
    Date Received
    September 3, 2019
    Decision Date
    June 22, 2020
    Product Code
    DSA
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DSA Cable, Transducer And Electrode, Patient, (Including Connector)

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    Other Clearances by Shenzhen Coreray Technology, Ltd.

    K Number Device Name
    K173368 Reusable & Disposable SpO2 Sensors
    K172797 ECG Cable/Leadwires